- Legend Biotech USA, Inc. (Raritan, NJ)
- …the development of the GMP Compliance program related to clinical / commercial stage and manufacturing.Support Legend's regulatory program and monitor the ... and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a key leader in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully informed of the overall ... and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans for successful… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of integrated ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …RD teams, ensuring ESC objectives are aligned and embedded in evidence generation, medical strategy, and clinical development plans, where appropriate. Gains ... areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Global Oncology Medical Affairs, External Scientific Collaboration role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and announcement, in coordination with Medical Director and Medical Information /Education functionContribute to development of medical communication ... external stakeholder, co- development company, including authors, researchers, investigators, GMA medical leads, RD clinical leads, bio stats and Publications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across several functions within Global Oncology Medical Affairs, Regional Medical Affairs, Precision Medicine, Clinical Development , RWE/HEOR, Discovery ... business decisions- Influence and inform cross-functional strategies across Precision Medicine, Clinical Development , Commercial and Market Access strategies to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the pharmaceutical industry with expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director...health authority regulatory requirements particularly in the areas of Medical Affairs and Clinical Development ;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction ... of the Senior Director , GMA Oncology ADC (Global Medical Affairs...projects within a specific compound or indication.Responsibilities- Leads the development of the Global Medical Affairs strategy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US...Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA strategy and medical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant ... anchored in disease biology and drug mechanism of action, aligned with clinical development required- Deep knowledge in pathology-based and other biomarker… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical and Safety sub-teams, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... the activities in the GMA plan.Responsibilities- Responsible for the development of the Global Medical Affairs early...model the way and enable the team to act.Provides medical leadership to:- GMA clinical operations teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg,… more
- Merck & Co. (Rahway, NJ)
- …innovative medicine.The Clinical Director is responsible for protocol development and medical / scientific oversight of clinical research studies ... incumbent will be accountable for developing and executing integrated development plans that align clinical , medical... Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and… more
- Merck & Co. (Rahway, NJ)
- …& Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle of ... affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director ... Clinical Studies, Clinical Trial Designs, Clinical Trials Monitoring, General Cardiology, Medical Monitoring,… more
- Formation Bio (New York, NY)
- …Study Planning and Execution: Development of protocol concepts, protocols and clinical development plans Medical leadership in the execution of ... a key member of the team, based on your clinical development experience you will be responsible...development experience you will be responsible for providing medical input into our Business Development product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Director Medical Review oversees a team of Medical Reviewers responsible for ... About the Department The Clinical , Medical and Regulatory (CMR) department...other safety reports pertaining to Novo Nordisk Products. The Medical Review Director is a key Leadership… more
- Merck & Co. (Rahway, NJ)
- …access and reimbursement. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, ... use by local subsidiaries in their HTA submissions.The Executive Director is expected to contribute to product development... clinical practiceDevelops a strong matrix relationship with clinical development , medical affairs, market… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent… more
- Merck & Co. (Rahway, NJ)
- …strategies for innovative combination products?Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development , and ... delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRaw Materials & Medical Device Director , Small Molecule Analytical Research & Development The Small Molecule Analytical Research and ... activities partnering across the network to enable clinical supplies. In this role, the Director of the Raw Materials and Medical Devices will lead a team of… more
