- Merck & Co. (Rahway, NJ)
- …support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior Director, Associate ... , the Clinical Director will manage the entire cycle of clinical development , including determination of appropriate disease indications to pursue and… more
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, ... disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning... project as neededLead biostatistics in early or late clinical development planning to ensure that study… more
- Merck & Co. (Rahway, NJ)
- …our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting corporate communications, serving as the ... priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery activities (user research, interviews, surveys, usability testing) in… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging Discovery Research through Late-Stage Clinical Development . The Therapeutic Area (TA) Lead will provide strategic oversight ... direction of clinical programs involving translational research and early clinical development for the Neuroscience Therapeutic Area. They are expected… more
- Merck & Co. (Rahway, NJ)
- …IT Global Medical Proficiency and External Affairs (GMPEA) Global Clinical Development (GCD)Required Qualifications, Skills, & ExperienceMinimumAdvanced Degree ... Job DescriptionRole SummaryThe Director Scientific Patient Engagement Lead is responsible for developing and implementing a global headquarters strategic patient… more
- Merck & Co. (Rahway, NJ)
- …plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s). Lead establishment of test methodologies, including method development ... (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead / Support clinical supplies production with respect to device… more
- Merck & Co. (Rahway, NJ)
- …public health organizations and their leadersRequired Skills: Advisory Board Development , Clinical Affairs, Clinical Development , Clinical Trials, ... in policy, communications, medical affairs, and PI&ELead the team's engagement with Global Clinical Trial Operations (GCTO) and Data Project Lead (DLP) teams to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Development and Commercialization Team (DCT) leader is-accountable for delivering a fully integrated stage-appropriate CMC development and ... influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team's strategy to ensure a robust CMC strategy is achieved.-… 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 ... as well as Outcomes Research.Under the guidance of a senior leader, this position leads a team of outcomes... clinical practiceDevelops a strong matrix relationship with clinical development , medical affairs, market access, commercial,… more
- Formation Bio (New York, NY)
- …an experienced and forward-thinking Senior Director of Toxicology to join our Development team. In this role, you will lead our toxicology efforts, ... will be a key member of the Formation Bio Development team.About the Role Build and lead ...and oversee the execution of toxicology studies to support clinical development and regulatory submissions Contribute toxicology… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionFrom its roots as a clinical development company, Formation Bio is harnessing the power of deep ... learning and artificial intelligence to break clinical development paradigms and transform how drugs...Why Join Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical… 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 ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Formation Bio (New York, NY)
- …scalable curation workflows. Data Modeling, Ontology-Driven Harmonization & Unstructured Integration Lead development of robust SQL/dbt models that unify complex ... 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… 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,...the roleWe are looking for a driven and organized senior accountant who is excited to join a fast-paced… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic leadership for global outsourcing and vendor management activities within clinical development . This role is accountable for designing and ... Salary Transparency Language:The annual base salary range for the Senior Director, Clinical Outsourcing is from :$223,800-$293,800Under current… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Eisai, Inc (Nutley, NJ)
- …Information plan for their assigned therapeutic area. Utilize scientific expertise to lead the development and maintenance of medical information resources for ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).-Where ... with different levels of study governance, as required-Oversee the development of the clinical study plan including...The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for… more
