- Merck & Co. (Rahway, NJ)
- …Evaluating pre- clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug ... all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...Director will manage the entire cycle of late-stage clinical development and studies, including development… 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 and biologics are developed. We are acquiring and developing… 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
- Merck & Co. (Rahway, NJ)
- …drive efficient, discovery facing innovations and decision-making strategy for all elements of early development . They will lead various early development ... (TPP) to define clear device requirements aligned with commercial and clinical goals.Construct overall development strategies, timelines, and transition plans… more
- Merck & Co. (Rahway, NJ)
- …benchmarking, and recommendations for commercialization strategies, portfolio prioritization, clinical development /research strategies, and Business ... Business Operations, Business Strategies, Chronic Obstructive Pulmonary Disease (COPD), Clinical Development , Clinical Research, Communication, Data-Driven… more
- Merck & Co. (Rahway, NJ)
- …pre- clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing ... involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of … more
- Merck & Co. (Rahway, NJ)
- …around the world.Reporting to the Associate Vice President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director , Digital Regulatory ... for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D) priorities, including prioritized roadmaps and investment cases to deliver… 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 ...enable the team to act.Provides medical leadership to:- GMA clinical operations teams as part of evidence generation forums… more
- Merck & Co. (Rahway, NJ)
- … & Technology (DD&T) engaged across the entire product lifecycle-from early development through commercialization and post-market activities-ensuring integration ... Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary...to the HF team and key stakeholders across R&D, clinical , regulatory, marketing, manufacturing, and quality functions.Educate and build… 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 ... management to share lessons learned and best practices across the Study Management Organization. The Director can serve as an SDL at early stages before an SDL… 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)
- … Clinical Trials, Communication, Cross-Functional Team Leadership, Data Analysis, Early Clinical Development , Good Manufacturing Practices (GMP), ... conferences. Under the supervision of the Director /Associate Director , they collaborate in the development of...of interest or strong scientific background Understanding of the clinical development process, clinical study… more
- Organon & Co. (Jersey City, NJ)
- …DMPK, and pharmacology, serving a key function within the Translational Medicine and Early Development (TMED) team. Non- Clinical Operations Lead will report ... Description** **The Position** The Non- Clinical Operations Lead within the Non- Clinical Development Team (NCD), is responsible for operational oversight… more
- Organon & Co. (Jersey City, NJ)
- …years of experience in the pharmaceutical or biotech industry with a focus in early clinical development , translational medicine and/or clinical ... quality thereof. The director may represent the Clinical Pharmacology function in asset development teams...working knowledge of regulatory guidance and requirements pertaining to early clinical development including … more
- Organon & Co. (Jersey City, NJ)
- …regulatory submissions. **Responsibilities** + Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure optimal ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on...knowledge-sharing events. + Contribute to and/or review the nonclinical, early clinical development or CMC… more
- Organon & Co. (Jersey City, NJ)
- …field. + Five years of industry experience? in R&D functions (eg, Clinical Research, Early Development , Medical Affairs, Pharmacovigilance, Regulatory ... **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful...Worked on programs in one or more phases of development (discovery, non- clinical , Phase 1, 2, 3,… more
- Merck & Co. (Rahway, NJ)
- …complex peptide/protein modalities). We collaborate closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and ... are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization...execute strategy for biological characterization in all stages of clinical development , as well as for commercialization… more
- Organon & Co. (Jersey City, NJ)
- …Excel. + A minimum of five to six years-experience in translational medicine and early clinical development within the pharmaceutical or biotech industry ... Clinical Trial Manager (CTM), Translational Medicine and Early Development (TMED) is responsible for assisting...phase 2a studies and will report to the Executive Director , TMED Operations. The CTM will support the TMED… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . **Job Title** Director , Early Clinical Development - Immunology ... **Functional Area Description** The Early Clinical Development - Immunology function is part of a global scientific organization dedicated to initial… more
- Pfizer (New York, NY)
- …members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the ... Oncology Drug Development especially in Early Development + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA,… more
