64 director jobs found

Merck Job Description Director - Discovery Oncology Discovery Oncology is seeking a visionary and driven people leader to discover and advance the next Oncology therapeutics. Come join an incredible team steeped in a history of scientific excellence and successful drug discovery. The successful candidate will lead a team at our company's Boston site focused on immune engaging biologics as well as additional modalities. They will partner across to help build our Discovery Oncology strategy and our expanding pipeline. This leader will work tightly with clinical, translational, and business development colleagues to ensure an effective pipeline of compelling medicines. The successful candidate will have a strong record of scientific excellence, thoughtful strategic planning, and inspiring people leadership. Responsibilities Be a creative and forward thinking leader to design and execute on the future of our company's Oncology therapeutics, particularly T cell...

Merck Job Description Digital is the multiplier that will allow Development Sciences and Clinical Supply (DSCS) to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is tasked with the mission to pioneer and deploy innovative digital technologies that drive the acquisition, automation and utilization of data to enhance insights, efficiency, and quality of DSCS processes and methods. The Executive Director of Digital Insights will lead multidisciplinary digital teams focused on building robust data pipelines, developing advanced data visualizations, and delivering in silico tools and predictive science solutions. The leader will help drive the digital transformation of R&D and manufacturing processes inclusive of drug substance, drug product and analytical efforts and all therapeutic modalities, ensuring seamless integration of...

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 Process Engineering Lead drives process development expertise, equipment and facility optimization, and new capabilities across all non-sterile development facilities. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of formulations in support of oral and combination products using the talent, capabilities, and facilities of the FLEx Center. They will be responsible for developing equipment and process subject matter experts who will partner with formulators and device engineers to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Formulation Sciences, Device Development,...

Merck Job Description Digital is the multiplier that will allow Development Sciences and Clinical Supply (DSCS) to deliver better experiments faster, efficient filing and launch, more robust supply chains and higher-confidence decisions across the portfolio. The DSCS Digital Technologies organization is tasked with the mission to pioneer and deploy innovative digital technologies that drive the acquisition, automation and utilization of data to enhance insights, efficiency, and quality of DSCS processes and methods. The Executive Director of Digital Insights will lead multidisciplinary digital teams focused on building robust data pipelines, developing advanced data visualizations, and delivering in silico tools and predictive science solutions. The leader will help drive the digital transformation of R&D and manufacturing processes inclusive of drug substance, drug product and analytical efforts and all therapeutic modalities, ensuring seamless integration of...

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 Process Engineering Lead drives process development expertise, equipment and facility optimization, and new capabilities across all non-sterile development facilities. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of formulations in support of oral and combination products using the talent, capabilities, and facilities of the FLEx Center. They will be responsible for developing equipment and process subject matter experts who will partner with formulators and device engineers to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Formulation Sciences, Device Development,...

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As a Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will serve as a Regulatory Lead for pipeline drug development programs and marketed products, and will be responsible for developing, implementing, and driving global Regulatory strategies. The ideal candidate will have a strong scientific background, broad experience developing drugs, and the ability to leverage that experience to impact program teams beyond regulatory strategy. This role reports to the Executive Director, Regulatory Strategy. Responsibilities Serve as Regulatory Lead, representing the Global Regulatory Team on cross-functional development teams Develop and implement global regulatory strategies for pipeline drug...

Alkermes, Inc. Alkermes has an exciting opportunity for a talented scientist to join our Research Organization as a Director to help lead medicinal chemistry efforts from target ideation through to candidate nomination for neurological disease indications. The desired candidate will be a recognized expert in successfully initiating and managing the medicinal chemistry activities inside a given portfolio and will play a key strategic role in shaping discovery direction and compound design strategy. The candidate will have a proven track record of utilizing structure-based drug design (SBDD) to rationally design compounds that have progressed to candidate delivery. Additionally, the candidate must have direct experience of working with both internal and external partners (e.g., CROs) to facilitate medicinal chemistry activities. Exceptional cross-functional communication skills as well as experience in leading drug discovery teams are necessary attributes. Responsibilities...

Alkermes, Inc. Alkermes is seeking an experienced Program Manager to support our ALKS 2680 program which is currently in Phase 2 development and preparing for Phase 3 and registration. ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy and idiopathic hypersomnia. This person will work closely with members across our organization including areas such as research, pre-clinical, clinical, pharmaceutical development, regulatory affairs, medical affairs, commercial, operations, policy and government affairs, patient engagement and corporate communications, as well as the senior management team to orchestrate development and execution of our fully-integrated program strategic and operational plans to support key corporate goals including the development and ultimate approval of ALKS 2680 as well as identify and execute a comprehensive lifecycle management program. This is a hybrid on-site...

The Nature Conservancy What We Can Achieve Together: The WY Director of External Affairs leads the Business Unit's (BU) external affairs functions, implements BU policy strategies, and provides guidance to program directors and staff on TNC's conservation policy priorities. The WY Director of External Affairs works with government and business entities to further the BU's mission in support of conservation policy and climate action and on behalf of TNC's North America Policy and Government Relations (NAPGR) policy goals. They monitor legislative, administrative, and corporate initiatives and policies that can impact the Wyoming BU's conservation programs. Duties include regular contact with local, county, state, federal, and country-level officials, agencies and corporate representatives. They represent and promote The Nature Conservancy's policy positions before special interest groups, government and business officials. The Director also works closely with Development,...

Alkermes, Inc. In this leadership position, the Senior Director, Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes' growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work Duties and Responsibilities: Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical...

Alkermes, Inc. The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects,...

Alkermes, Inc. The Sr. Medical Director/Medical Director, Global Safety Officer (GSO) will work closely with the DSPV leadership team and will provide strategic safety oversight, for the assigned investigational and/or marketed products, for the Alkermes Neuroscience portfolio. Reporting to the Head of DSPV, the GSO will serve in a visible role in providing safety advisement in several company-wide forums and initiatives. Demonstrated prior career success as a product safety physician, having led clinical and post-marketing programs as the Safety lead, working in close partnership with the cross-functional teams. This individual will be responsible for collaborating and working effectively with key stakeholders and keeping the DSPV leadership informed of evolving safety issues and strategies. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently...

Alkermes, Inc. This position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources. This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues. Travel requirement of 40% - 60% Responsibilities This position will : Schedule, personally conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to: Audits of clinical vendors, clinical sites...

Alkermes, Inc. The Executive Medical Director serves as a senior member of the DSPV leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives. The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to...

Alkermes, Inc. The Associate Director, Regulatory Operations will be responsible for submission management across the development pipeline and support the commercial portfolio. This hands-on position will also assist with regulatory affairs systems, applications, and tools including supporting system implementations, maintenance, updates, and releases. You'll work closely with Regulatory Affairs and cross-functional partners to manage timelines, ensure submission readiness, and strengthen operational excellence across the organization. Key Responsibilities: Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables. This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities. Serve as submission manager and primary contact for publishing vendors and internal stakeholders....

Alkermes, Inc. We are seeking a highly motivated and strategic individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes' most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees...

Alkermes, Inc. Reporting to the Vice President, Regulatory Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary. Responsibilities Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future therapeutic priorities and interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project...

Merck Job Description The FLEx Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. The FLEx organization has a mission to enable development of our Company's pipeline products with speed, agility, and rigor. This mission will be accomplished by: 1) Enabling robust formulation and process development with flexible physical and digital infrastructure; 2) Delivering compliant, high quality clinical supplies; 3) Developing talents with a new operating model and promoting a growth mindset. The FLEx organization is seeking a highly motivated individual to serve the role of MES Specialist. The successful candidate will support the deployment and sustainment of a Manufacturing Execution System (MES) at the FLEx Center to enable Electronic Batch Records (EBR), Electronic Logs (E-Logs), and Weigh & Dispense functionality. The individual will help to ensure that the MES system...