49 manager product development jobs found

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Merck Job Description The Executive Director, Customer Service Center Strategy & Ops Leader (ED, CSC) reports to the Associate Vice President of US Marketing Operations in Commercial Excellence & Innovation and leads the overall US Customer Service Center organization with accountability to direct the strategy and execution of engagements with Healthcare Professionals, Patients, Consumers, and Employees across five contact centers with primary focus in the US. This accountability extends to include operational performance, regulatorycompliant intake, and largescale service modernization. This role directs a complex, multilayered organization of approximately 80 Full Time Employees, including multi-level leaders, people managers, and frontline teams responsible for critical, highly regulated customer and patient interactions. The ED, CSC sets the vision, strategy, and governance for a critical service organization that supports Healthcare Professionals, consumers,...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Clinical Operations, the Manager, Clinical Operations will ensure excellence in clinical trial planning, execution, and data collection, in accordance with regulatory guidelines. They will be responsible for aspects of clinical study conduct, including site selection, study start-up, conduct and close-out. Providing appropriate escalation of trial specific issues to deliver high quality clinical trial results. Able to adapt to changes in the work environment and manage competing demands. Responsibilities: Manage multiple aspects of clinical...

Collegium Pharmaceutical Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. Hybrid: Required to be onsite in Stoughton, MA on Tuesday, Wednesday and Thursday. POSITION OVERVIEW The Manager, Quality Assurance will be responsible for supporting the manufacturing, testing, and release of drug products for clinical and commercial use. They will ensure compliance with all aspects of 21CFR *210, *211, and *820 cGMP. This role will be responsible for providing leadership in the management of critical quality systems (i.e. : Batch Disposition, Investigations (Deviation / Product Complaint), CAPAs, Change Control, etc. ) that allow the company to maintain all licenses to operate. This individual will be critical in supporting interdepartmental and cross functional project...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Associate Director, Corporate Strategy, the Senior Manager, Competitive Intelligence (CI), will support CI activities across Nuvalent's portfolio. CI is a key function within Nuvalent, and this role is a great opportunity to have broad visibility across the organization. The key focus for this role is driver mutated solid tumors, particularly ALK+, ROS1+, and HER2m NSCLC. The role also includes monitoring of the strategies, programs, and capabilities of competitors in research, development, and promotional areas, as well as overall industry trends. Within this role,...

Biogen As the Pharmacovigilance Agreement (PVA) Senior Manager, you collaborate with varied levels of cross-functional internal and external global stakeholders in all aspects of timely execution and maintenance of safety data exchange agreements (SDEAs) and pharmacovigilance agreements (PVAs) with Corporate Partners. The PVA Senior Manager is integral to the planning, visualization, and archival systems required for on-time development and marketed product SDEAs, PV transfer agreements, and for inspection readiness. This individual contributor role reports to the Head of PV Alliance Management (PVAM) and contributes directly to Biogen's product pipeline and portfolio. What You'll Do Conduct timely outreach for SDEA planning, authoring and stakeholder and corporate partner transparency Manage the SDEA tracker and produce accurate SDEA planning reports and other required status reports Act as an SDEA subject matter expert for audit and inspections and SDEA inbox...

Biogen About This Role: As the Senior Manager of Value Evidence Strategy, you will be integral to designing and executing evidence-generation activities that support both global and regional market access objectives. Positioned within the Global Value & Access Team, you will manage specific research projects focused on real-world evidence, patient-reported outcomes, and health economic modeling. This role requires close collaboration with cross-functional partners, including Market Access, Medical Affairs, Clinical Development, and Epidemiology, to translate evidence into compelling value narratives for stakeholders. Reporting to the Head of Value Evidence Strategy, you'll play a crucial role in coordinating workstreams across sub-functions and leading collaborative efforts with external partners, enhancing our strategic alignment and driving success in market access initiatives. What You'll Do: Lead strategic research projects supporting pipeline product...

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Nuvalent, Inc. The Company: With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building. The Role: Reporting to the Senior Director, Payer & Reimbursement, the Associate Director, Pricing & Contracting Operations plays a critical role in shaping and executing the company's pricing and contracting strategies to optimize access to Nuvalent's product portfolio, as well as playing a key part in driving pricing and contracting strategy and management. We are a growing pharmaceutical company with a commitment to delivering innovative, oral targeted therapies for oncology patients. We are seeking a dynamic and strategic professional to lead pricing and contracting operations....

Merck Job Description Position Description The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) function of our Research & Development Division in West Point, Pennsylvania, is seeking a highly skilled and motivated Scientist to join the Transporter Science Group. The Transporter Science group is a center of excellence to design, execute, and integrate transporter related in vitro and preclinical studies to support our Company's Portfolio through all stages of drug discovery and development. We are also driving cutting edge ADME-transporter science via development and implementation of novel in vitro and preclinical models, as well as translational approaches to enhance our capabilities to quantitatively predict the roles of transporters on ADME, drug-drug interactions (DDIs), efficacy, and toxicity of drugs in a diversified portfolio that spans various therapeutic areas and modalities. In this position, candidates will be responsible to generate...

Merck Job Description The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Sterile Process Engineer at the Associate Director level will serve as a technical subject matter expert in process development, equipment and facility optimization, and new capabilities across the sterile development facility. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of a portfolio of sterile drug product formulations using the capabilities and facilities of the FLEx Center. They will be responsible for the technical mentorship and coordination of work for process engineering colleagues to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Sterile Product Development,...

Merck Job Description The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Sterile Process Engineer at the Associate Director level will serve as a technical subject matter expert in process development, equipment and facility optimization, and new capabilities across the sterile development facility. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of a portfolio of sterile drug product formulations using the capabilities and facilities of the FLEx Center. They will be responsible for the technical mentorship and coordination of work for process engineering colleagues to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Sterile Product Development,...

Merck Job Description We are seeking a highly motivated and detailoriented Scientist to join our highthroughput Protein Engineering team in South San Francisco, CA. The successful candidate will support the discovery and optimization of novel biologics through highthroughput protein production, analytics, and screening. This role offers an excellent opportunity for an earlycareer scientist to make a direct impact on therapeutic protein discovery in a collaborative, fastpaced, and innovationdriven environment. The position sits at the intersection of molecular biology, automation, and cuttingedge biologics discovery, providing handson exposure to modern protein engineering platforms. This role contributes to our company's mission to accelerate drug development by supporting conventional, computational, and AI/MLenabled approaches to biologics discovery. We recognize that our team is our strength and are committed to creating an inclusive environment for all employees....

Biogen About This Role The Global SMA/ALS Medical Lead will be a strategic partner providing medical leadership, people management and expertise to all related SMA/ALS portfolio activities to improve meaningful patient outcomes. You will build and maintain external relationships among medical experts globally and be accountable for the development and implementation of the Global SMA/ALS Medical Strategy in close collaboration with Global/ICOE/regional cross functional and medical colleagues. In collaboration with the relevant medical and cross-functional partners (R&D, V&A, Commercial, Program Leadership) at Biogen, you will ensure key medical insights relevant for data generation, publication efforts, and medical education strategy are understood and executed in a prioritized manner. You will lead the Global SMA/ALS Medical team, providing a balanced approach to oversight and growth opportunities. Biogen's priority is to continue to foster and enable a diverse and...

Merck Job Description Associate Scientist, Post Doctoral Fellow-Systems Biology/Virology Our company is a global health care leader with a portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Job description: Applications are sought for a post-doctoral opportunity in the company's Research Labs division of our company. The individual will support our company's discovery & development efforts at West Point, PA. The company's Research Labs, is looking...

Biogen This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and...

Biogen About This Role: As Biogen's Access Management Service Delivery Manager (SDM) you are the Access Management subject matter expert and services leader for all Access Management activities at Biogen. This role is accountable for delivering value to global stakeholders - which includes access services to every application in Biogen. A peer to this role is the Service Delivery Manager of Identity. This role is a direct report of the Global Leader of Identity and Access Management and is a member of the extended leadership team within the Cybersecurity organization. As Access Management SDM, you are responsible for establishing access management policies and standards and keeping them current. You are responsible for the planning and execution of initiatives that improve access management capabilities - both central platforms or efforts supporting independent stakeholder applications. This role is responsible for the entire service delivery process, from planning and...

Biogen About This Role: As the Director of the Rare Disease Reimbursement Management (RDRM) team, you will play a crucial role in leading and supporting the efforts of our team to navigate and manage the reimbursement landscape for Spinal Muscular Atrophy (SMA), SOD-1 ALS, and Friedreich's Ataxia (FA). Your leadership will be pivotal in ensuring proactive management of reimbursement environments, working closely with Account Management, Sales, and Family Access teams to implement effective reimbursement and clinical education strategies across the U.S. This role involves the selection, onboarding, coaching for performance and development, and managing employee processes. You will also lead the delivery of clinical education and in-service support to treatment sites, becoming an expert on SMA, ALS, and FA reimbursement policies, and translating local and national payer policies into actionable strategies. Collaborating with MA&R teams, you'll identify trends, provide...