Glaukos Corporation

Careers

Glaukos is a company with great ambition. We are committed to transforming the management of glaucoma with a comprehensive portfolio of micro-scale therapies designed to address the complete range of glaucoma disease states and progression.  We are continually adding to our team of dynamic, driven and seasoned professionals.

At Glaukos we have a strong sense of accountability and commitment to producing outcomes.  We are a group of individuals who thrive on teamwork and a healthy sense of competitiveness. Headquartered in Orange County, California, we encourage our employees to balance work and personal activities and to spend quality time with family and friends.

Glaukos offers all employees competitive compensation packages that includes base salary, bonus potential and stock options.  We are a growing company with big company benefits, which include medical, dental, vision and flex plans; a 401(k) retirement program; and life/accidental death and dismemberment and long-term disability insurance.  In addition, we offer an Employee Stock Purchase Plan (ESPP).

Glaukos Corporation is an Equal Opportunity/ Affirmative Action employer.

Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Chemist III/Staff Chemist position supports research and development of intra-ocular drug delivery and/or glaucoma devices and inserters, and can also be a supervisor for the junior members of R&D staff, such as chemistry interns and chemist I positions. In addition to providing technical input to Applied Research projects, this position is expected to contribute to cross-functional teams within the company. Responsibilities:   API FORMULATIONS Characterize formulations for suitability in implant models   DRUG ASSAYS Develop and conduct assay methods to quantify drug concentration in solutions by HPLC   GMP MANUFACTURING Participate in GMP builds of product for in vivo studies   API STABILITY STUDIES Characterize stability of API’s by potency, purity, and impurity methods   SUPERVISION OF JUNIOR STAFF Advisory role, time cards, personnel issues   Chemist III: Minimum of 5 years of experience in medical device or pharmaceutical research. Prior research in another field may be substituted if there is sufficient evidence of laboratory skill developed in that field. Staff Chemist: Minimum of 8 years of experience in medical device or pharmaceutical research. Prior research in another field may be substituted if there is sufficient evidence of laboratory skill developed in that field.     Knowledge, Skills and Abilities:  • Glaukos’ drug delivery project is not to be disclosed during recruitment process.  Instead, the job will be described as development of biocompatible coatings for our stents. • A knowledge of eye anatomy, physiology, and disease a strong plus. • Biocompatible or bioactive molecule-eluting coatings (such as for cardiovascular stents or pacemaker leads), including preclinical validation, a strong plus. • Glaukos is a small, entrepreneurial company where each person is responsible for many different functions.  We are looking for a person who will flourish in this kind of environment—a hands-on, self-motivated individual who can develop new chemistries and analytical methods with minimal direction. • A versatile hands-on bench chemist, an individual contributor • Analytical methods such as HPLC-MS (High Performance Liquid Chromatography, Mass Spectroscopy).    Education: BS in Chemistry, Chemical Engineering, or related discipline. An advanced degree is helpful but not required. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Biomedical Engineer position based in San Clemente, CA, supports research and development of intra-ocular drug delivery designs. The focus for this position is to design and fabricate test articles for in vivo and in vitro testing of drug delivery devices for the eye. This engineer will also design and fabricate custom equipment for R&D and pilot scale manufacturing. Responsibilities:   Design of drug delivery test articles: ·       Take input from R&D scientists and translate these into workable design options suitable for in vitro and in vivo applications ·       Fabricate designs with state-of-the-art micro-machining, molding, and extrusion methods ·       Use Solidworks to create CAD files and work with vendors to obtain designed parts ·       Follow document control requirements for medical device industry Design of experiments: ·       Complete experimental designs ·       Execute experiments ·       Analyze data and collaborate with project team on design iterations ·       Write study reports Assist with analytical work      ·       Use HPLC methods to analyze API content & delivery of devices ·       Use Spectroscopy (FTIR, UV-vis) to analyze materials In vivo studies ·       Participate in protocol design for in vivo studies ·       Attend in vivo studies to learn anatomy and physiology of the eye; generate feedback on designs of drug delivery test articles Inserter design ·       Assist in design and development of prototype inserters for ophthalmic studies   Work Experience: ·       Minimum of 3 years of experience in ophthalmic or medical device development. ·       Prior experience in another field may be substituted if there is an excellent skill fit.   Knowledge, Skills and Abilities: ·       Knowledge of anatomy, physiology, and diseases of the eye. This may be augmented through Glaukos course training. ·       Familiarity with Solidworks and knowledge of drawings and CAD files used for device-design required. ·       Hands-on, self-motivated individual who can conceive, design, generate CAD files and work with vendors to obtained finished parts. ·       Familiarity with analytical methods using HPLC. ·       Working knowledge of quality systems for medical devices. ·       Ability to write test reports with minimal supervision is required.   Education: ·       BS biomedical, mechanical, or chemical engineering or related discipline. An advanced degree is a plus. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Sr. Scientist, will be based within the Translational Sciences department within the Applied Research organization working on the Pharmacokinetic evaluations of novel or reformulated chemical and biological entities compatible with the company’s drug delivery device technologies.  This individual will be responsible for the development and execution of the pharmacokinetic and PK/PD studies supporting the overall development plan for the pharmaceutical combination projects. The successful candidate will be expected to provide expertise in PK and PK/PD study design, protocol development and execution, data analysis, modeling, interpretation and reporting.  Apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data.  Also assess PKPD properties of drug candidates based on preclinical data.  Author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures. He/She will work independently while also collaborating within the group and across functional groups, matrix teams.  Responsibilities:   Designs and conducts pharmacokinetic research for the advancement of NCEs and reformulations from discovery through development. Based on corporate strategic objectives, develops pharmacokinetic research plans that lead to the enhancement of the company's technology and intellectual property (i.e., concepts, patents, techniques, product registration).  Conducts due diligence and feasibility assessments for business development activities.   Provide expertise within Translational Research and inter-departmentally to fulfill pharmacokinetic, pharmacodynamic, toxicodynamic, and local drug delivery initiatives.  Designs and executes PK and PK/PD study protocols, analyses and models data and writes internal study reports and oversees and monitors PK study conduct and reporting at CROs.   Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting of MB objectives. Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas. Recommends to management the purchase or modification of equipment, facility renovations, and allocation of resources to meet strategic pharmacokinetic and R&D objectives.   Writes expert opinions, reports and regulatory submissions to meet marketing registration needs for products. Stays fully informed of advancements in biologics research and development and regulatory positions to advise and adjust research direction to ensure products will meet objectives for regulatory and medical needs.   Acts as a representative for the company to outside parties and regulatory agencies for Glaukos products. Attends scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge in field of specialization. Writes patents, scientific articles and makes presentations at national scientific meetings. Stays abreast of technological advancements through extensive reading of internal and external reports, scientific findings, professional journals, and regulatory positions.   Work Experience:    • Broad understanding of pharmacokinetics and PKPD modeling strategies and hand’s on experience with PK and PK/PD modeling tools (i.e. Phoenix/Winonlin, NonMem) • Experience in analyzing and reporting nonclinical PK study data and human PK from clinical trials • Effective written and verbal communication skills; strong understanding of regulatory environment to support regulatory and corporate agencies. • Experience in writing sections 2.4 and 2.6 of CTDs • Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate. Ability to work within a diverse workforce. • Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Education: Ph.D. with 4-6 years of relevant industry experience.  We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Director, Field Reimbursement, field-based position (ideally based in California - or surrounding states) is focused on providing internal and external customers with complete and accurate information on coding, coverage and payment, as well as obtaining coverage and adequate payment from regional payers/economic buyers for Glaukos devices. Additionally, this Director, Field Reimbursement will assist the US sales force in discussing practice economics, hospital economics, and provider reimbursement with key targeted customers. Duties include tactical activities in support of customers and field based sales personnel to support the adoption of Glaukos devices.  Key functions to include coding and payment analysis, health technology assessment preparation,  insurance authorization analysis, coverage analysis, cost effectiveness analysis, and building relationships with regional payers and targeted providers  Creates awareness among key healthcare decision makers and payers to ensure a favorable government and private reimbursement environment, improving acceptance and increasing adoption of Glaukos devices and the procedures in which they are utilized. Responsibilities:   ·         Develop and implement a focused payer and managed care plan based on key local and regional government and commercial payers ·         Identifies the managed health care opportunities and barriers to entry. Works with assigned payers and providers to establish or change  coverage and payment policies. ·         Develops and manages a network of payer reimbursement contacts and data to assist in the research and tactical implementation of the payer plan. ·         Establishes strong relationships as the key contact with payers by fostering mutually beneficial long term benefits. Works with medical societies representing physician customers to achieve appropriate coding and payment. ·         Provide informational programs and collateral support materials to Glaukos customers to optimize product reimbursement. ·         Delivers presentations to payers to establish and/or improve reimbursement coverage policies, coding and payment assignments utilizing available resources: ·         Works with state and local professional societies as well as federal agencies to ensure patient access. ·         Health Economics ·         Comparative Effectiveness Data ·         Key Opinion Leader Physicians ·         Works with internal reimbursement team, and external reimbursement consultants as appropriate, to develop tools for customers focused on creating access for patients, through accurate and current coding information. ·         Works with new and existing accounts to identify and coordinate education needs. ·         Evaluates incoming requests from the field and ensures each request is properly evaluated for feasibility, technical risk, cost and time constraints, compliance and other relevant considerations. ·         Distributes pre-authorization materials, accurate information to customers; tracks and reports on trends. ·         Assists in addressing appeals for authorization and payment. ·         Manages hotline, email and web inquiries on a timely basis. ·         Promotes reimbursement support and represents the company to external customers by writing, phoning, visiting, hosting and participating in events. ·         Remains aware of changing reimbursement environment by interacting with field contacts, attending professional seminars/conferences and reading industry journals and web news. Evaluates levels of customer support and improves them. ·         Provide informational programs and collateral support to Glaukos customers to support practice economics around Glaukos portfolio products ·         Working with the regional business managers, provide customers with latest provider reimbursement and facility reimbursement education ·         Works to educate targeted customers on practice economics when using Glaukos portfolio products ·         Leads discussions with financial decision makers in hospitals, ASC, and physician groups on the economics of Glaukos portfolio products Develops materials to effectively communicate the economics of Glaukos portfolio products ·         Daily activities include: o   Works to solve situational reimbursement/coverage related issues as they arise. o   Provide accurate and current information to Glaukos customers to support field sales through management of reimbursement issues and programs, interpretation of policy and training of physicians, facilities and staff members in reimbursement and coding. o   Assist customers with achieving appropriate reimbursement and understanding reimbursement tactics for meeting payer requirements for documentation of medical necessity. o   Respond to coverage, coding, and payment inquiries from providers by offering objective information based upon qualified and recognized reimbursement sources that may assist the physician in making an informed coding determination based on the procedure to be performed with a Glaukos device. o   Track payer/provider trends by geography. ·         Other duties as assigned. Work Experience:    ·         8+ years of experience in reimbursement / healthcare policy development ·         5+ years of experience in reimbursement and healthcare policy development ·         Knowledge of managed care and health insurance industry ·         Experience working with organizational decision makers – marketing, regulatory and sales managers ·         Experience working directly with sales representatives ·         Attention to detail ·         Demonstrated knowledge and experience in payer (Medicare, Medicaid, and Private) policies, reimbursement process and the health care legislative environment ·         Experience in interacting effectively with payer decision-makers, health care reimbursement professionals and local carrier medical directors ·         Experience in using clinical data to support reimbursement position in presentations ·         Knowledge of health care provider issues related to reimbursement and practice economics ·         Experience working with reimbursement strategies and tactics ·         Working knowledge of computer software including Word, Excel, PowerPoint and MS Project ·         Project management skills ·         Ability to travel to payer and prospective customer/customer sites ·         Ability to follow and implement policies and procedures required of this position ·         Detailed knowledge of insurance companies including government payers (Medicare, Medicaid, Tricare) and private payers (PPOs and HMOs) with regard to professional and facility payment systems ·         Effective communication and presentation skills, strong telephone skills ·         Well-organized, self-motivated ·         Occasional weekend work commitment Education: ·         Bachelor (BA/BS) degree We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: Clinical Research Associate – Field Based:  California Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) may also assist in the development, analysis, and execution of a clinical study. This job description attempts to capture only the primary and most identifiable tasks of this position. Main Duties: Clinical Research Monitoring ·         Travel to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits. ·         Verify informed consent procedures are properly followed. ·         Evaluate investigator compliance with the study protocol and applicable regulations. ·         Verify sites are collecting all required source data per protocol, accurately transcribing onto Case Report Forms, and resolving all data queries. ·         Collect and submit CRFs and data queries to Data Management vendor. ·         Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed. ·         Verify essential documents are both filed in the site’s regulatory binder and the study master file as required. ·         Capture, document, and communicate Adverse Event information in accordance with the study protocol and regulatory requirements. ·         Verify investigational product is properly stored, dispensed, and returned, and that accountability of the product and masking requirements are maintained throughout the study. ·         Assist with selection of potential investigators. ·         FOR PRINCIPAL – In addition to responsibilities above, a Principal CRA serves as regional expert on clinical and protocol matters. Clinical Site Management ·         Maintain frequent contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study. ·         Assist site with development of essential study documents and IRB submissions/approvals. Verify all essential documents are properly executed and prepared prior to shipment of investigational product. ·         Prepare and verify proper execution of all required investigator agreements, including Non-Disclosure Agreement, Investigator Agreement, and Compensation Agreement. ·         Purchase equipment for clinical sites as required by the study protocol and with management approval. ·         Develop project plans (e.g., to increase enrollment, motivational ideas, etc.), identify problems that interfere with study progress, and implement strategies to resolve issues. ·         Prepare faxes, newsletters, and other forms of communication to assist with enrollment and study compliance at clinical sites. Clinical Study Execution ·         Be familiar with study timelines and budget, and communicate potential issues to management. ·         Monitor and track study implementation and progress, including provision of information to management for grant payments to the sites. ·         Track, post on the shared drive, and file essential documents in the study master file. ·         Assist in preparation and planning for investigator meetings. ·         May be responsible for or assist with management of outside vendors, including Contract Research Organizations, Data Management vendor, reading centers, CRF printers, etc. ·         May mentor/train other CRAs and clinical staff, including assessing monitoring skills by traveling with the CRA to a site visit. ·         May assist with the development of study protocols, investigator brochures, site-specific instruction manuals, case report form designs, patient information documents, monitoring plans, informed consents, site training documents, and source document templates. ·         May participate in preparation of regulatory submissions necessary to initiate and maintain clinical studies and marketing approvals, including clinical study reports, safety reports, and annual reports. Requirements Education: ·         Level I Bachelor’s degree preferred in biological science, nursing, or other related discipline. ·         Levels II+ Bachelor’s degree or equivalent experience required in biological science, nursing, or other related discipline. Work Experience: ·         Level I At least 2 years direct clinical research experience. ·         Level II At least 2 years work experience as a CRA; 5 years direct clinical research experience. ·         Level Sr At least 5 years work experience as a CRA; 8 years direct clinical research experience. ·         Level Princ At least 8 years work experience as a CRA; 10 years direct clinical research experience. ·         Experience in the medical device industry is a plus. ·          Ophthalmology experience is required for all levels of a CRA. Knowledge, Skills and Abilities: ·         Knowledge and understanding of ICH E6: Good Clinical Practices. ·         Knowledge and understanding of FDAs Code of Federal Regulations applicable to conducting clinical research studies. ·         Must have excellent organizational skills. ·         Must have the ability to communicate effectively, both written and verbal, with excellent customer service capabilities. ·         Should have proactive approach to problem solving and good problem solving skills. ·         Must have proficient computer skills and experience with Microsoft Office applications, i.e., Word, Excel, Outlook, PowerPoint and Access. ·         Experience with Electronic Data Capture is beneficial. ·         Must be willing and able to travel approximately 70%, including overnight, domestic and international. ·         Perform any other related duties as assigned or required. Level I ·         Have worked with, reviewed, and filed clinical study essential documents as a research assistant, coordinator, or CRA at either a site or sponsor level. ·         Have been responsible for tracking and receipt of clinical study elements, including investigational product distribution, site visits and visit reports, enrollment, CRFs and DCFs, and collection or management of essential documents. ·         Have been responsible for managing or ordering investigational product shipments. ·         Have experience with CRF binders and study supplies. Levels II, Sr, Principal – In addition to those items listed under Level I: ·         Have conducted all types of site visits. ·         Have mentored or been involved in the training of another CRA or clinical assistant. ·         Has been involved in the development of study documents and site-specific tools, for example, protocol, CRFs, source document templates, informed consent template. Principal – In addition to those items listed under Level I, II and Sr.: ·         Proven ability to provide insight and expertise as a regional expert. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Chemist II position supports research and development of intra-ocular drug delivery and/or glaucomadevices and inserters. The majority of this support is maintenance and executionof HPLC method assays for therapeutic drug compounds. In addition to chemist Iduties, this position is expected to be capable of method development withlittle to no supervision from more senior chemists. This position is alsoresponsible for handling the GMP controlled studies that require knowledge ofGMP methodology. Responsibilities:   HPLC: Maintenance, method validations, and assays. GMP Testing Protocols: Write, review, and execute GMP tests. GMP Manufacturing:  Participate in GMP builds of product for in vivo studies. API Stability Studies:  Characterize stability of API’s by potency, purity, and impurity methods.   Work Experience: · Minimumof 3 years of experience in medical device development or pharmaceuticaldevelopment. Prior research in another field may be substituted if there issufficient evidence of laboratory skill developed in that field. · Previous experience with HPLC is required. Knowledge, Skills and Abilities: ·      Ophthalmicknowledge of eye anatomy, physiology, and diseases. This may be acquiredthrough Glaukos course training. ·      Hands-on,self-motivated individual who can execute analytical methods with moderatedirection. ·      Knowledgeof analytical methods beyond HPLC such as HPLC-MS (High Performance LiquidChromatography-Mass Spectroscopy) Working knowledge of Quality Systems and GMP methods. Ability to execute GMP protocols with minimal supervision. Education: BS in Chemistry, Chemical Engineering, or related discipline. An advanced degree is helpful but not required. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.   Position Overview: The Market Access Manager , based in Germany, will be responsible for developing and overseeing all market entry strategies for Glaukos portfolio products in Central European region, with primary responsibility for Germany. Responsibilities include the development of payment pathways with national, regional, and/or local payers. Assess market access barriers and develop necessary strategies to overcome.  Responsible for regional/local evidence development and modeling in conjunction with health economics team to support local reimbursement applications and future Health Technology Assessments.  Manages the Health Technology Assessment process in Central Europe region and ensures clinical and economic evidence supports effective HTA process. Responsible for all government affairs activities in Central Europe region including developing relations with government and private stakeholders to ensure optimized coding, coverage, and payment of Glaukos portfolio technology. Responsibilities:   Develop and implement a focused market access plan for Germany and Central Europe: ·         Provides strategic direction on market access pathways for portfolio products; including assessments of potential new markets and technologies in Central Europe region ·         Responsible for execution of regional KV access, reduction/elimination of Single Patient Application Forms, where still required ·         Responsible for advocating for proper coding, coverage, and payment for current and future technologies ·         Responsible for strategic vision and tactical implementation of reimbursement strategies ·         Responsible for developing  relationships with government payers, medical device societies, and patient advocacy groups to ensure patient access to our technology platform in Central Europe region ·         Leads clinical and economic evidence development for assigned region in collaboration with global health economics including but not limited to pharmacoeconomic models, economic studies, cost effectiveness models, and budget impact models.  ·         Synthesizes input from Medical Affairs, Health Economic & Outcomes Research, Market Access, Market Research, etc., as appropriate to identify & analyze trends and/or changes which will influence Market Access now & in the future.  Determine implications for Glaukos. ·         Build & maintain a solid command on external trends through product case studies, advisory boards, conferences, relationships, & competitive intelligence. ·         Support commercial teams on educating and empowering with market access knowledge. Provide informational programs and collateral support materials to Glaukos   customers to optimize product reimbursement: ·         Delivers presentations to payers to establish and/or improve reimbursement coverage policies, coding and payment assignments utilizing available resources: Health Economics Comparative Effectiveness Data Key Opinion Leader Physicians ·         Responsible for market access material generations, adaptation, and gain appropriate internal approvals. ·         Works with regional and country professional societies as well as government agencies to ensure patient access. ·         Works with internal reimbursement team, and external reimbursement consultants as appropriate, to develop tools for customers focused on creating access for patients, through accurate and current coding information.  ·         Works with new and existing accounts to identify and coordinate education needs. ·         Evaluates incoming requests from the field and ensures each request is properly evaluated for feasibility, technical risk, cost and time constraints, compliance and other relevant considerations. ·         Promotes reimbursement support and represents the company to external customers by writing, phoning, visiting, hosting and participating in events. ·         Remains aware of changing reimbursement environment by interacting with field contacts, attending professional seminars/conferences and reading industry journals and web news. ·         Evaluates levels of customer support and improves them. Daily Activities: ·         Leads Central Europe market access team ·         Provides strategic direction to the VP, Commercial, Central Europe for all market access activities in region related to Glaukos portfolio products Work Experience:    ·   10+ yrs. of medical device marketing, market access and/or management experience is required preferably within ophthalmic surgical or pharmaceutical areas. ·   Candidate must have had prior global market access experience and has a demonstrating track record of obtaining medical device reimbursement around the world and has successfully managed health technology assessments. ·   Candidate should also have experience in a business development, strategy, and/or corporate development role within a medical device or pharmaceutical company. ·   Experience managing people within marketing, market access, and/or business development function with a global scope and a track record for success. International experience is strongly preferred. Knowledge, Skills and Abilities: ·         Excellent written and verbal communication skills with ability to speak to all levels of the organization. ·         Solid industry working knowledge with existing KOLs, thought leaders, medical societies, lobbying organizations, payers, and HTA relationships. Ability to develop and build relationships with all constituents quickly, both internally and externally, to drive results. ·         Cross functional knowledge and strong interpersonal skills within a team environment to influence others toward business results including Finance, RA/QA, Sales/Marketing, Ops, International Management, Medical Affairs, Clinical Affairs, Business Development, Product Development, Clinical Training, and Human Relations & Administration. Education: ·         Bachelor’s degree in Science, Business, or Marketing. ·         Advanced degree or MBA is preferred. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. #LI-POST
Glaukos Corporation Germany, , Germany
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Clinical Relations Manager, based in the Central Northeast, will be responsible for developing programs to identify and educate prospective study subjects and health care professionals about clinical trial participation. Works synergistically with the Regional Business Sales Manager (RBM) in targeted accounts to maximize commercial growth. Responsibilities:   CLINICAL STUDY recruitment & LEADERSHIP: A.         Leads clinical recruitment efforts on key US IDE and post-approval trials. Acts as an integral member of the core project team working directly with the Clinical Affairs team (Directors or Managers of Clinical Affairs, and Clinical Research Associates) and the Surgical Specialists (Regional Business Managers), and any other relevant team members. B.         Develops strong personal relationships with study investigators, clinical coordinators, and glaucoma/cataract key opinion leaders. C.        Initiates and cultivates open, honest relationships with colleagues, investigators and study staff, contractors, and vendors by developing an understanding of others’ needs, promoting common goals, and following through on commitments. D.        Establishes and builds rapport with clinical sites and assess their recruitment challenges and opportunities. E.         Based on a thorough assessment, develops a detailed and specific subject recruitment plan for clinical sites participating in Glaukos-sponsored studies. F.         Implements and facilitates subject recruitment and retention activities. G.        Analyzes metrics to identify trends, issues, areas of success and for improvement. A.         Identifies and proposes strategies, procedures, systems, technology etc. to improve productivity and efficiencies in clinical trial subject recruitment. B.         Develops detailed site specific study pre-screening plans based on protocol inclusion/exclusion criteria. Performs and oversees patient chart reviews to identify potential study subjects. C.        Complies with HIPAA, pertinent federal and state laws and regulations, and relevant Glaukos internal procedures. D.        Identifies outreach opportunities to educate patients, health care professionals, advocacy groups, and potential referring physicians about study participation. E.         Monitors referral sources to ensure adequate study information is provided to potential participants. F.         Identifies, coordinates, and staffs appropriate events and meetings, as needed. G.        Proactively and effectively communicates updates on site status to clinical management, Clinical Affairs, and RBMs. Communicates trends in the industry and, whenever possible, status of competitive clinical trials. H.        Determines best practices for working with sites on increasing subject enrollment.  I.          Works with other respective Manager, Clinical Relations to elevate team success. J.         Attends major ophthalmic meetings, as needed. COMMUNICATION AND EVENT ORGANIZATION A.         Provide training to ophthalmology practices on how to properly and efficiently identify patients within their practice who are potential candidates for commercial iStent implantation. B.         Employ effective tools and programs to properly communicate the potential benefits of iStent implantation to appropriately identified patients. Work Experience:    Minimum 10 years relevant work experience in the medical device or pharmaceutical industry, preferably with experience in ophthalmology and medical devices.  •           Knowledge of medical terminology required, with knowledge of ophthalmology terminology strongly preferred •           Knowledge of operation room procedures and protocols •           Ability to problem solve complex issues without comes that ensure best outcome for patients •           Prior experience in business development or as a study coordinator or clinical research assistant desirable •           Knowledge of the medical, scientific, design, and clinical research aspect of medical device and/or pharmaceutical trials •           Strong communication, interpersonal, and analytical skills •           Excellent time management and organizational skills •           Experience in MS Office (Outlook, Word, Excel); familiarity with databases helpful •           Self-motivated and able to work independently, as well as within a team in a multidisciplinary environment •           Must be willing and able to travel a significant amount of time (> 50%) •           Flexibility, as assignments vary in location, time intensity Exhibits personal integrity, credibility, and responsibility Education: Bachelor’s degree required, with major in biological science, nursing, or other health-related discipline preferred. Certified Ophthalmic Assistance or Ophthalmic Technician Certification strongly preferred. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Glaukos Corporation New York, , United States
Mar 31, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Area Director, field-based in Dallas, Texas is responsible for hitting top line sales and profitability goals for the Western United States. Leads sales force in training of surgeons in clinical studies, achieve enrollment goals and assure excellent outcomes. Executes marketing strategy to assure sales force accomplishes these goals with the approved tasks.   Responsibilities:   ATTAIN SALES AND PROFITABILITY GOALS FOR UNITED STATES: •           Achieve assigned Area quota and other sales metrics. •           Develop and manage sales budget for assigned Area. Analyze and control department expenditures to conform to budgetary requirements. •           Recruit, hire, and train Regional Business Managers to hit regional goals that are in line with company goals. •           Be the “expert” in any and all things that the sales force requires, surgical technique, managing quarterly MBOs, credentialing requirements for surgery etc. •           Manage Key Opinion Leaders within Area and assist in training and monitoring of our most influential implanters. •           Work in the field to lead by example to show RBMs what Glaukos expects on a day to day basis. •           Attend, national, regional state and local ophthalmology meetings. •           Attend iStent surgery with all technologies to assure technique is being followed and report back to commercial, R&D and clinical if new ideas can be implemented. •           Help the sales team to integrate and follow through with reimbursement of the iStent in ASCs/ Hospitals and physician offices. •           Work to help the sales force implement practice marketing to identify more patients for iStent when the surgeon has become confident with the procedure. •           Execute company education and training for employees and RBM’s. •           Monitor and evaluate the activities and products of competitors in the market.  SUPPORT CLINICAL TRAILS: •           Meet with physicians/investigators to maintain and build relationships to facilitate patient enrollment in support of U.S. clinical trials. •           Conduct Investigator site visits to work with and provide direction to physicians and staff on surgical technique of implantation of the iStent. •           Train sales team to be an expert in surgery to assist the surgeon with technique, paperwork and follow through with the clinical team •           Support international trial activities by serving as management representative and surgical specialist as requested.             GENERAL SUPPORT : •           React to change productively and handle other essential tasks as assigned. •           Recognize that quality begins with each employee and embrace the Quality Policy.   Work Experience:    •          10 plus years in sales and marketing in ophthalmic-related industry.  At least 4 years senior management experience. •           Must have extraordinary communication skills.  Must have the ability to give presentations to Physicians/Investigators and Board of Directors. •           Must be able to create reports, budgets, and presentations using Word, Excel, and PowerPoint. •           Proven record in setting and meeting objectives. •           Skilled in educating and providing hands-on training to physicians/investigators. •           Experience with clinical trials and the ability to assist sites in increasing enrollment . Education: •          4 year college degree preferred or 15 years in sales with increasing management responsibilities. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation Dallas, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Chemist III/Staff Chemist position supports research and development of intra-ocular drug delivery and/or glaucoma devices and inserters, and can also be a supervisor for the junior members of R&D staff, such as chemistry interns and chemist I positions. In addition to providing technical input to Applied Research projects, this position is expected to contribute to cross-functional teams within the company. Responsibilities:   API FORMULATIONS Characterize formulations for suitability in implant models   DRUG ASSAYS Develop and conduct assay methods to quantify drug concentration in solutions by HPLC   GMP MANUFACTURING Participate in GMP builds of product for in vivo studies   API STABILITY STUDIES Characterize stability of API’s by potency, purity, and impurity methods   SUPERVISION OF JUNIOR STAFF Advisory role, time cards, personnel issues   Chemist III: Minimum of 5 years of experience in medical device or pharmaceutical research. Prior research in another field may be substituted if there is sufficient evidence of laboratory skill developed in that field. Staff Chemist: Minimum of 8 years of experience in medical device or pharmaceutical research. Prior research in another field may be substituted if there is sufficient evidence of laboratory skill developed in that field.     Knowledge, Skills and Abilities:  • Glaukos’ drug delivery project is not to be disclosed during recruitment process.  Instead, the job will be described as development of biocompatible coatings for our stents. • A knowledge of eye anatomy, physiology, and disease a strong plus. • Biocompatible or bioactive molecule-eluting coatings (such as for cardiovascular stents or pacemaker leads), including preclinical validation, a strong plus. • Glaukos is a small, entrepreneurial company where each person is responsible for many different functions.  We are looking for a person who will flourish in this kind of environment—a hands-on, self-motivated individual who can develop new chemistries and analytical methods with minimal direction. • A versatile hands-on bench chemist, an individual contributor • Analytical methods such as HPLC-MS (High Performance Liquid Chromatography, Mass Spectroscopy).    Education: BS in Chemistry, Chemical Engineering, or related discipline. An advanced degree is helpful but not required. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Biomedical Engineer position based in San Clemente, CA, supports research and development of intra-ocular drug delivery designs. The focus for this position is to design and fabricate test articles for in vivo and in vitro testing of drug delivery devices for the eye. This engineer will also design and fabricate custom equipment for R&D and pilot scale manufacturing. Responsibilities:   Design of drug delivery test articles: ·       Take input from R&D scientists and translate these into workable design options suitable for in vitro and in vivo applications ·       Fabricate designs with state-of-the-art micro-machining, molding, and extrusion methods ·       Use Solidworks to create CAD files and work with vendors to obtain designed parts ·       Follow document control requirements for medical device industry Design of experiments: ·       Complete experimental designs ·       Execute experiments ·       Analyze data and collaborate with project team on design iterations ·       Write study reports Assist with analytical work      ·       Use HPLC methods to analyze API content & delivery of devices ·       Use Spectroscopy (FTIR, UV-vis) to analyze materials In vivo studies ·       Participate in protocol design for in vivo studies ·       Attend in vivo studies to learn anatomy and physiology of the eye; generate feedback on designs of drug delivery test articles Inserter design ·       Assist in design and development of prototype inserters for ophthalmic studies   Work Experience: ·       Minimum of 3 years of experience in ophthalmic or medical device development. ·       Prior experience in another field may be substituted if there is an excellent skill fit.   Knowledge, Skills and Abilities: ·       Knowledge of anatomy, physiology, and diseases of the eye. This may be augmented through Glaukos course training. ·       Familiarity with Solidworks and knowledge of drawings and CAD files used for device-design required. ·       Hands-on, self-motivated individual who can conceive, design, generate CAD files and work with vendors to obtained finished parts. ·       Familiarity with analytical methods using HPLC. ·       Working knowledge of quality systems for medical devices. ·       Ability to write test reports with minimal supervision is required.   Education: ·       BS biomedical, mechanical, or chemical engineering or related discipline. An advanced degree is a plus. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Sr. Scientist, will be based within the Translational Sciences department within the Applied Research organization working on the Pharmacokinetic evaluations of novel or reformulated chemical and biological entities compatible with the company’s drug delivery device technologies.  This individual will be responsible for the development and execution of the pharmacokinetic and PK/PD studies supporting the overall development plan for the pharmaceutical combination projects. The successful candidate will be expected to provide expertise in PK and PK/PD study design, protocol development and execution, data analysis, modeling, interpretation and reporting.  Apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data.  Also assess PKPD properties of drug candidates based on preclinical data.  Author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures. He/She will work independently while also collaborating within the group and across functional groups, matrix teams.  Responsibilities:   Designs and conducts pharmacokinetic research for the advancement of NCEs and reformulations from discovery through development. Based on corporate strategic objectives, develops pharmacokinetic research plans that lead to the enhancement of the company's technology and intellectual property (i.e., concepts, patents, techniques, product registration).  Conducts due diligence and feasibility assessments for business development activities.   Provide expertise within Translational Research and inter-departmentally to fulfill pharmacokinetic, pharmacodynamic, toxicodynamic, and local drug delivery initiatives.  Designs and executes PK and PK/PD study protocols, analyses and models data and writes internal study reports and oversees and monitors PK study conduct and reporting at CROs.   Provides regular and open communication to keep project teams, and management informed of direction, progress and strategic developments in supporting and meeting of MB objectives. Actively participates in departmental committees/meetings as an advisor in scientific, administrative and regulatory areas. Recommends to management the purchase or modification of equipment, facility renovations, and allocation of resources to meet strategic pharmacokinetic and R&D objectives.   Writes expert opinions, reports and regulatory submissions to meet marketing registration needs for products. Stays fully informed of advancements in biologics research and development and regulatory positions to advise and adjust research direction to ensure products will meet objectives for regulatory and medical needs.   Acts as a representative for the company to outside parties and regulatory agencies for Glaukos products. Attends scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge in field of specialization. Writes patents, scientific articles and makes presentations at national scientific meetings. Stays abreast of technological advancements through extensive reading of internal and external reports, scientific findings, professional journals, and regulatory positions.   Work Experience:    • Broad understanding of pharmacokinetics and PKPD modeling strategies and hand’s on experience with PK and PK/PD modeling tools (i.e. Phoenix/Winonlin, NonMem) • Experience in analyzing and reporting nonclinical PK study data and human PK from clinical trials • Effective written and verbal communication skills; strong understanding of regulatory environment to support regulatory and corporate agencies. • Experience in writing sections 2.4 and 2.6 of CTDs • Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate. Ability to work within a diverse workforce. • Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies. Education: Ph.D. with 4-6 years of relevant industry experience.  We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Director, Field Reimbursement, field-based position (ideally based in California - or surrounding states) is focused on providing internal and external customers with complete and accurate information on coding, coverage and payment, as well as obtaining coverage and adequate payment from regional payers/economic buyers for Glaukos devices. Additionally, this Director, Field Reimbursement will assist the US sales force in discussing practice economics, hospital economics, and provider reimbursement with key targeted customers. Duties include tactical activities in support of customers and field based sales personnel to support the adoption of Glaukos devices.  Key functions to include coding and payment analysis, health technology assessment preparation,  insurance authorization analysis, coverage analysis, cost effectiveness analysis, and building relationships with regional payers and targeted providers  Creates awareness among key healthcare decision makers and payers to ensure a favorable government and private reimbursement environment, improving acceptance and increasing adoption of Glaukos devices and the procedures in which they are utilized. Responsibilities:   ·         Develop and implement a focused payer and managed care plan based on key local and regional government and commercial payers ·         Identifies the managed health care opportunities and barriers to entry. Works with assigned payers and providers to establish or change  coverage and payment policies. ·         Develops and manages a network of payer reimbursement contacts and data to assist in the research and tactical implementation of the payer plan. ·         Establishes strong relationships as the key contact with payers by fostering mutually beneficial long term benefits. Works with medical societies representing physician customers to achieve appropriate coding and payment. ·         Provide informational programs and collateral support materials to Glaukos customers to optimize product reimbursement. ·         Delivers presentations to payers to establish and/or improve reimbursement coverage policies, coding and payment assignments utilizing available resources: ·         Works with state and local professional societies as well as federal agencies to ensure patient access. ·         Health Economics ·         Comparative Effectiveness Data ·         Key Opinion Leader Physicians ·         Works with internal reimbursement team, and external reimbursement consultants as appropriate, to develop tools for customers focused on creating access for patients, through accurate and current coding information. ·         Works with new and existing accounts to identify and coordinate education needs. ·         Evaluates incoming requests from the field and ensures each request is properly evaluated for feasibility, technical risk, cost and time constraints, compliance and other relevant considerations. ·         Distributes pre-authorization materials, accurate information to customers; tracks and reports on trends. ·         Assists in addressing appeals for authorization and payment. ·         Manages hotline, email and web inquiries on a timely basis. ·         Promotes reimbursement support and represents the company to external customers by writing, phoning, visiting, hosting and participating in events. ·         Remains aware of changing reimbursement environment by interacting with field contacts, attending professional seminars/conferences and reading industry journals and web news. Evaluates levels of customer support and improves them. ·         Provide informational programs and collateral support to Glaukos customers to support practice economics around Glaukos portfolio products ·         Working with the regional business managers, provide customers with latest provider reimbursement and facility reimbursement education ·         Works to educate targeted customers on practice economics when using Glaukos portfolio products ·         Leads discussions with financial decision makers in hospitals, ASC, and physician groups on the economics of Glaukos portfolio products Develops materials to effectively communicate the economics of Glaukos portfolio products ·         Daily activities include: o   Works to solve situational reimbursement/coverage related issues as they arise. o   Provide accurate and current information to Glaukos customers to support field sales through management of reimbursement issues and programs, interpretation of policy and training of physicians, facilities and staff members in reimbursement and coding. o   Assist customers with achieving appropriate reimbursement and understanding reimbursement tactics for meeting payer requirements for documentation of medical necessity. o   Respond to coverage, coding, and payment inquiries from providers by offering objective information based upon qualified and recognized reimbursement sources that may assist the physician in making an informed coding determination based on the procedure to be performed with a Glaukos device. o   Track payer/provider trends by geography. ·         Other duties as assigned. Work Experience:    ·         8+ years of experience in reimbursement / healthcare policy development ·         5+ years of experience in reimbursement and healthcare policy development ·         Knowledge of managed care and health insurance industry ·         Experience working with organizational decision makers – marketing, regulatory and sales managers ·         Experience working directly with sales representatives ·         Attention to detail ·         Demonstrated knowledge and experience in payer (Medicare, Medicaid, and Private) policies, reimbursement process and the health care legislative environment ·         Experience in interacting effectively with payer decision-makers, health care reimbursement professionals and local carrier medical directors ·         Experience in using clinical data to support reimbursement position in presentations ·         Knowledge of health care provider issues related to reimbursement and practice economics ·         Experience working with reimbursement strategies and tactics ·         Working knowledge of computer software including Word, Excel, PowerPoint and MS Project ·         Project management skills ·         Ability to travel to payer and prospective customer/customer sites ·         Ability to follow and implement policies and procedures required of this position ·         Detailed knowledge of insurance companies including government payers (Medicare, Medicaid, Tricare) and private payers (PPOs and HMOs) with regard to professional and facility payment systems ·         Effective communication and presentation skills, strong telephone skills ·         Well-organized, self-motivated ·         Occasional weekend work commitment Education: ·         Bachelor (BA/BS) degree We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: Clinical Research Associate – Field Based:  California Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) may also assist in the development, analysis, and execution of a clinical study. This job description attempts to capture only the primary and most identifiable tasks of this position. Main Duties: Clinical Research Monitoring ·         Travel to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits. ·         Verify informed consent procedures are properly followed. ·         Evaluate investigator compliance with the study protocol and applicable regulations. ·         Verify sites are collecting all required source data per protocol, accurately transcribing onto Case Report Forms, and resolving all data queries. ·         Collect and submit CRFs and data queries to Data Management vendor. ·         Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed. ·         Verify essential documents are both filed in the site’s regulatory binder and the study master file as required. ·         Capture, document, and communicate Adverse Event information in accordance with the study protocol and regulatory requirements. ·         Verify investigational product is properly stored, dispensed, and returned, and that accountability of the product and masking requirements are maintained throughout the study. ·         Assist with selection of potential investigators. ·         FOR PRINCIPAL – In addition to responsibilities above, a Principal CRA serves as regional expert on clinical and protocol matters. Clinical Site Management ·         Maintain frequent contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study. ·         Assist site with development of essential study documents and IRB submissions/approvals. Verify all essential documents are properly executed and prepared prior to shipment of investigational product. ·         Prepare and verify proper execution of all required investigator agreements, including Non-Disclosure Agreement, Investigator Agreement, and Compensation Agreement. ·         Purchase equipment for clinical sites as required by the study protocol and with management approval. ·         Develop project plans (e.g., to increase enrollment, motivational ideas, etc.), identify problems that interfere with study progress, and implement strategies to resolve issues. ·         Prepare faxes, newsletters, and other forms of communication to assist with enrollment and study compliance at clinical sites. Clinical Study Execution ·         Be familiar with study timelines and budget, and communicate potential issues to management. ·         Monitor and track study implementation and progress, including provision of information to management for grant payments to the sites. ·         Track, post on the shared drive, and file essential documents in the study master file. ·         Assist in preparation and planning for investigator meetings. ·         May be responsible for or assist with management of outside vendors, including Contract Research Organizations, Data Management vendor, reading centers, CRF printers, etc. ·         May mentor/train other CRAs and clinical staff, including assessing monitoring skills by traveling with the CRA to a site visit. ·         May assist with the development of study protocols, investigator brochures, site-specific instruction manuals, case report form designs, patient information documents, monitoring plans, informed consents, site training documents, and source document templates. ·         May participate in preparation of regulatory submissions necessary to initiate and maintain clinical studies and marketing approvals, including clinical study reports, safety reports, and annual reports. Requirements Education: ·         Level I Bachelor’s degree preferred in biological science, nursing, or other related discipline. ·         Levels II+ Bachelor’s degree or equivalent experience required in biological science, nursing, or other related discipline. Work Experience: ·         Level I At least 2 years direct clinical research experience. ·         Level II At least 2 years work experience as a CRA; 5 years direct clinical research experience. ·         Level Sr At least 5 years work experience as a CRA; 8 years direct clinical research experience. ·         Level Princ At least 8 years work experience as a CRA; 10 years direct clinical research experience. ·         Experience in the medical device industry is a plus. ·          Ophthalmology experience is required for all levels of a CRA. Knowledge, Skills and Abilities: ·         Knowledge and understanding of ICH E6: Good Clinical Practices. ·         Knowledge and understanding of FDAs Code of Federal Regulations applicable to conducting clinical research studies. ·         Must have excellent organizational skills. ·         Must have the ability to communicate effectively, both written and verbal, with excellent customer service capabilities. ·         Should have proactive approach to problem solving and good problem solving skills. ·         Must have proficient computer skills and experience with Microsoft Office applications, i.e., Word, Excel, Outlook, PowerPoint and Access. ·         Experience with Electronic Data Capture is beneficial. ·         Must be willing and able to travel approximately 70%, including overnight, domestic and international. ·         Perform any other related duties as assigned or required. Level I ·         Have worked with, reviewed, and filed clinical study essential documents as a research assistant, coordinator, or CRA at either a site or sponsor level. ·         Have been responsible for tracking and receipt of clinical study elements, including investigational product distribution, site visits and visit reports, enrollment, CRFs and DCFs, and collection or management of essential documents. ·         Have been responsible for managing or ordering investigational product shipments. ·         Have experience with CRF binders and study supplies. Levels II, Sr, Principal – In addition to those items listed under Level I: ·         Have conducted all types of site visits. ·         Have mentored or been involved in the training of another CRA or clinical assistant. ·         Has been involved in the development of study documents and site-specific tools, for example, protocol, CRFs, source document templates, informed consent template. Principal – In addition to those items listed under Level I, II and Sr.: ·         Proven ability to provide insight and expertise as a regional expert. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Chemist II position supports research and development of intra-ocular drug delivery and/or glaucomadevices and inserters. The majority of this support is maintenance and executionof HPLC method assays for therapeutic drug compounds. In addition to chemist Iduties, this position is expected to be capable of method development withlittle to no supervision from more senior chemists. This position is alsoresponsible for handling the GMP controlled studies that require knowledge ofGMP methodology. Responsibilities:   HPLC: Maintenance, method validations, and assays. GMP Testing Protocols: Write, review, and execute GMP tests. GMP Manufacturing:  Participate in GMP builds of product for in vivo studies. API Stability Studies:  Characterize stability of API’s by potency, purity, and impurity methods.   Work Experience: · Minimumof 3 years of experience in medical device development or pharmaceuticaldevelopment. Prior research in another field may be substituted if there issufficient evidence of laboratory skill developed in that field. · Previous experience with HPLC is required. Knowledge, Skills and Abilities: ·      Ophthalmicknowledge of eye anatomy, physiology, and diseases. This may be acquiredthrough Glaukos course training. ·      Hands-on,self-motivated individual who can execute analytical methods with moderatedirection. ·      Knowledgeof analytical methods beyond HPLC such as HPLC-MS (High Performance LiquidChromatography-Mass Spectroscopy) Working knowledge of Quality Systems and GMP methods. Ability to execute GMP protocols with minimal supervision. Education: BS in Chemistry, Chemical Engineering, or related discipline. An advanced degree is helpful but not required. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation San Clemente, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.   Position Overview: The Market Access Manager , based in Germany, will be responsible for developing and overseeing all market entry strategies for Glaukos portfolio products in Central European region, with primary responsibility for Germany. Responsibilities include the development of payment pathways with national, regional, and/or local payers. Assess market access barriers and develop necessary strategies to overcome.  Responsible for regional/local evidence development and modeling in conjunction with health economics team to support local reimbursement applications and future Health Technology Assessments.  Manages the Health Technology Assessment process in Central Europe region and ensures clinical and economic evidence supports effective HTA process. Responsible for all government affairs activities in Central Europe region including developing relations with government and private stakeholders to ensure optimized coding, coverage, and payment of Glaukos portfolio technology. Responsibilities:   Develop and implement a focused market access plan for Germany and Central Europe: ·         Provides strategic direction on market access pathways for portfolio products; including assessments of potential new markets and technologies in Central Europe region ·         Responsible for execution of regional KV access, reduction/elimination of Single Patient Application Forms, where still required ·         Responsible for advocating for proper coding, coverage, and payment for current and future technologies ·         Responsible for strategic vision and tactical implementation of reimbursement strategies ·         Responsible for developing  relationships with government payers, medical device societies, and patient advocacy groups to ensure patient access to our technology platform in Central Europe region ·         Leads clinical and economic evidence development for assigned region in collaboration with global health economics including but not limited to pharmacoeconomic models, economic studies, cost effectiveness models, and budget impact models.  ·         Synthesizes input from Medical Affairs, Health Economic & Outcomes Research, Market Access, Market Research, etc., as appropriate to identify & analyze trends and/or changes which will influence Market Access now & in the future.  Determine implications for Glaukos. ·         Build & maintain a solid command on external trends through product case studies, advisory boards, conferences, relationships, & competitive intelligence. ·         Support commercial teams on educating and empowering with market access knowledge. Provide informational programs and collateral support materials to Glaukos   customers to optimize product reimbursement: ·         Delivers presentations to payers to establish and/or improve reimbursement coverage policies, coding and payment assignments utilizing available resources: Health Economics Comparative Effectiveness Data Key Opinion Leader Physicians ·         Responsible for market access material generations, adaptation, and gain appropriate internal approvals. ·         Works with regional and country professional societies as well as government agencies to ensure patient access. ·         Works with internal reimbursement team, and external reimbursement consultants as appropriate, to develop tools for customers focused on creating access for patients, through accurate and current coding information.  ·         Works with new and existing accounts to identify and coordinate education needs. ·         Evaluates incoming requests from the field and ensures each request is properly evaluated for feasibility, technical risk, cost and time constraints, compliance and other relevant considerations. ·         Promotes reimbursement support and represents the company to external customers by writing, phoning, visiting, hosting and participating in events. ·         Remains aware of changing reimbursement environment by interacting with field contacts, attending professional seminars/conferences and reading industry journals and web news. ·         Evaluates levels of customer support and improves them. Daily Activities: ·         Leads Central Europe market access team ·         Provides strategic direction to the VP, Commercial, Central Europe for all market access activities in region related to Glaukos portfolio products Work Experience:    ·   10+ yrs. of medical device marketing, market access and/or management experience is required preferably within ophthalmic surgical or pharmaceutical areas. ·   Candidate must have had prior global market access experience and has a demonstrating track record of obtaining medical device reimbursement around the world and has successfully managed health technology assessments. ·   Candidate should also have experience in a business development, strategy, and/or corporate development role within a medical device or pharmaceutical company. ·   Experience managing people within marketing, market access, and/or business development function with a global scope and a track record for success. International experience is strongly preferred. Knowledge, Skills and Abilities: ·         Excellent written and verbal communication skills with ability to speak to all levels of the organization. ·         Solid industry working knowledge with existing KOLs, thought leaders, medical societies, lobbying organizations, payers, and HTA relationships. Ability to develop and build relationships with all constituents quickly, both internally and externally, to drive results. ·         Cross functional knowledge and strong interpersonal skills within a team environment to influence others toward business results including Finance, RA/QA, Sales/Marketing, Ops, International Management, Medical Affairs, Clinical Affairs, Business Development, Product Development, Clinical Training, and Human Relations & Administration. Education: ·         Bachelor’s degree in Science, Business, or Marketing. ·         Advanced degree or MBA is preferred. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. #LI-POST
Glaukos Corporation Germany, , Germany
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Clinical Relations Manager, based in the Central Northeast, will be responsible for developing programs to identify and educate prospective study subjects and health care professionals about clinical trial participation. Works synergistically with the Regional Business Sales Manager (RBM) in targeted accounts to maximize commercial growth. Responsibilities:   CLINICAL STUDY recruitment & LEADERSHIP: A.         Leads clinical recruitment efforts on key US IDE and post-approval trials. Acts as an integral member of the core project team working directly with the Clinical Affairs team (Directors or Managers of Clinical Affairs, and Clinical Research Associates) and the Surgical Specialists (Regional Business Managers), and any other relevant team members. B.         Develops strong personal relationships with study investigators, clinical coordinators, and glaucoma/cataract key opinion leaders. C.        Initiates and cultivates open, honest relationships with colleagues, investigators and study staff, contractors, and vendors by developing an understanding of others’ needs, promoting common goals, and following through on commitments. D.        Establishes and builds rapport with clinical sites and assess their recruitment challenges and opportunities. E.         Based on a thorough assessment, develops a detailed and specific subject recruitment plan for clinical sites participating in Glaukos-sponsored studies. F.         Implements and facilitates subject recruitment and retention activities. G.        Analyzes metrics to identify trends, issues, areas of success and for improvement. A.         Identifies and proposes strategies, procedures, systems, technology etc. to improve productivity and efficiencies in clinical trial subject recruitment. B.         Develops detailed site specific study pre-screening plans based on protocol inclusion/exclusion criteria. Performs and oversees patient chart reviews to identify potential study subjects. C.        Complies with HIPAA, pertinent federal and state laws and regulations, and relevant Glaukos internal procedures. D.        Identifies outreach opportunities to educate patients, health care professionals, advocacy groups, and potential referring physicians about study participation. E.         Monitors referral sources to ensure adequate study information is provided to potential participants. F.         Identifies, coordinates, and staffs appropriate events and meetings, as needed. G.        Proactively and effectively communicates updates on site status to clinical management, Clinical Affairs, and RBMs. Communicates trends in the industry and, whenever possible, status of competitive clinical trials. H.        Determines best practices for working with sites on increasing subject enrollment.  I.          Works with other respective Manager, Clinical Relations to elevate team success. J.         Attends major ophthalmic meetings, as needed. COMMUNICATION AND EVENT ORGANIZATION A.         Provide training to ophthalmology practices on how to properly and efficiently identify patients within their practice who are potential candidates for commercial iStent implantation. B.         Employ effective tools and programs to properly communicate the potential benefits of iStent implantation to appropriately identified patients. Work Experience:    Minimum 10 years relevant work experience in the medical device or pharmaceutical industry, preferably with experience in ophthalmology and medical devices.  •           Knowledge of medical terminology required, with knowledge of ophthalmology terminology strongly preferred •           Knowledge of operation room procedures and protocols •           Ability to problem solve complex issues without comes that ensure best outcome for patients •           Prior experience in business development or as a study coordinator or clinical research assistant desirable •           Knowledge of the medical, scientific, design, and clinical research aspect of medical device and/or pharmaceutical trials •           Strong communication, interpersonal, and analytical skills •           Excellent time management and organizational skills •           Experience in MS Office (Outlook, Word, Excel); familiarity with databases helpful •           Self-motivated and able to work independently, as well as within a team in a multidisciplinary environment •           Must be willing and able to travel a significant amount of time (> 50%) •           Flexibility, as assignments vary in location, time intensity Exhibits personal integrity, credibility, and responsibility Education: Bachelor’s degree required, with major in biological science, nursing, or other health-related discipline preferred. Certified Ophthalmic Assistance or Ophthalmic Technician Certification strongly preferred. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
Glaukos Corporation New York, , United States
Mar 24, 2018
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.  Position Overview: The Area Director, field-based in Dallas, Texas is responsible for hitting top line sales and profitability goals for the Western United States. Leads sales force in training of surgeons in clinical studies, achieve enrollment goals and assure excellent outcomes. Executes marketing strategy to assure sales force accomplishes these goals with the approved tasks.   Responsibilities:   ATTAIN SALES AND PROFITABILITY GOALS FOR UNITED STATES: •           Achieve assigned Area quota and other sales metrics. •           Develop and manage sales budget for assigned Area. Analyze and control department expenditures to conform to budgetary requirements. •           Recruit, hire, and train Regional Business Managers to hit regional goals that are in line with company goals. •           Be the “expert” in any and all things that the sales force requires, surgical technique, managing quarterly MBOs, credentialing requirements for surgery etc. •           Manage Key Opinion Leaders within Area and assist in training and monitoring of our most influential implanters. •           Work in the field to lead by example to show RBMs what Glaukos expects on a day to day basis. •           Attend, national, regional state and local ophthalmology meetings. •           Attend iStent surgery with all technologies to assure technique is being followed and report back to commercial, R&D and clinical if new ideas can be implemented. •           Help the sales team to integrate and follow through with reimbursement of the iStent in ASCs/ Hospitals and physician offices. •           Work to help the sales force implement practice marketing to identify more patients for iStent when the surgeon has become confident with the procedure. •           Execute company education and training for employees and RBM’s. •           Monitor and evaluate the activities and products of competitors in the market.  SUPPORT CLINICAL TRAILS: •           Meet with physicians/investigators to maintain and build relationships to facilitate patient enrollment in support of U.S. clinical trials. •           Conduct Investigator site visits to work with and provide direction to physicians and staff on surgical technique of implantation of the iStent. •           Train sales team to be an expert in surgery to assist the surgeon with technique, paperwork and follow through with the clinical team •           Support international trial activities by serving as management representative and surgical specialist as requested.             GENERAL SUPPORT : •           React to change productively and handle other essential tasks as assigned. •           Recognize that quality begins with each employee and embrace the Quality Policy.   Work Experience:    •          10 plus years in sales and marketing in ophthalmic-related industry.  At least 4 years senior management experience. •           Must have extraordinary communication skills.  Must have the ability to give presentations to Physicians/Investigators and Board of Directors. •           Must be able to create reports, budgets, and presentations using Word, Excel, and PowerPoint. •           Proven record in setting and meeting objectives. •           Skilled in educating and providing hands-on training to physicians/investigators. •           Experience with clinical trials and the ability to assist sites in increasing enrollment . Education: •          4 year college degree preferred or 15 years in sales with increasing management responsibilities. We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture:  https://www.themuse.com/companies/glaukoscorporation Glaukos has been recognized by the  Orange County Business Journal  as one of the best companies to work for in in Orange County, check out page 8 at  http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf   Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.      
Glaukos Corporation Dallas, , United States