- Formation Bio (New York, NY)
- …be part of that journey: As a key member of the team, based on your clinical development experience you will be responsible for providing medical input into our ... Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, including protocol … 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
- Merck & Co. (Rahway, NJ)
- …pipeline products to produce safe, effective, innovative medicine.The Clinical Director is responsible for protocol development and medical/ scientific ... clinical trial results.In addition to responsibilities associated with clinical research, the Clinical Director ... Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and… 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
- 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 ... regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or Associate… more
- Formation Bio (New York, NY)
- …for programs and clinical studies. Collaborate with cross-functional teams ( Clinical Development , Regulatory, Program Management, etc.) to shape and refine ... treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide... Clinical Development Plans, ensuring feasibility and operational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …workManage Publication tracking and announcement, in coordination with Medical Director and Medical Information /Education functionContribute to development ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …objectives are aligned and embedded in evidence generation, medical strategy, and clinical development plans, where appropriate. Gains strategic and planning ... areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Global Oncology Medical Affairs, External Scientific Collaboration role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 team lead...projects within a specific compound or indication.Responsibilities- Leads the development of the Global Medical Affairs strategy and execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within Global Oncology Medical Affairs, Regional Medical Affairs, Precision Medicine, Clinical Development , RWE/HEOR, Discovery and Business Development ... business decisions- Influence and inform cross-functional strategies across Precision Medicine, Clinical Development , Commercial and Market Access strategies to… more
- Merck & Co. (Rahway, NJ)
- …and reimbursement. The incumbent is expected to work cross-functionally with clinical development , medical affairs, biostatistics, market access, commercial, and ... therapies into clinical practiceDevelops a strong matrix relationship with clinical development , medical affairs, market access, commercial, and key markets… more
- 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)
- …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)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops… 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
- 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 ... execution of the activities in the GMA plan.Responsibilities- Responsible for the development of the Global Medical Affairs early strategy and medical objectives for… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,...investment transactions, and will work closely with the CFO, Director of Accounting, and Business Development teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality assessments).This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …, development of SBOs/KPIs, execution and oversight Partner with Director to implement and execute launch planning strategies, defines and drives NNI ... privacy, compliance and legal. Relationships The position reports to the Director , Patient Solutions and Field Reimbursement. Closely partners closely with MAPA,… more
