- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... areas centered around rare diseases and immune disorders. Summary Senior clinical operational leader accountable for operational planning and execution of FIH,… 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)
- …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
- 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)
- …GDIM to drive technology-enabled process improvements. Build strong relationships with clinical development , clinical sciences, regulatory, biostats, data ... strong collaboration. Partner with other functional excellence colleagues, such as clinical development , to ensure harmonization. Responsible for maintaining… 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)
- …analytic validation of digital pathology algorithms.Interface with scientists and physicians in early and late-stage clinical development to execute ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases… more
- Eisai, Inc (Nutley, NJ)
- …and oversight of Phase I through IV clinical trial programs and early new product development within the Medical Affairs department for assigned product(s). ... The Associate Medical Director utilizes expert medical, clinical and scientific...the design strategies, planning and implementation of Phase IV clinical development programs for assigned product(s).Create IIS… 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
- Insmed Incorporated (NJ)
- …Do: Lead development of HEOR strategy for gene therapy products from early clinical development through product launch and life cycle management.Ensure ... of science, we're in. Are you?About the Role:The Senior Director , HEOR is a strategic leader responsible for the...the company including market access, marketing, medical affairs, and clinical development to understand and support Insmed's… more
- Insmed Incorporated (NJ)
- …activities supporting clinical trial materials, including DS/DP used in early and late-phase studies.Oversee QA support for development -stage manufacturing, ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development .Demonstrated success in QA oversight of… 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
- Genmab (NJ)
- …join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both ... early and late-stage programs, and/or as trial responsible statistician...responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development … more
- Merck & Co. (Rahway, NJ)
- …Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... clinical to post-licensure). With a focus on late-stage development , the Senior Director will manage the... Director will manage the entire cycle of clinical development , including study design, initiation, execution,-monitoring,… 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
- Parexel (Trenton, NJ)
- …, which is expected to be kept up to date. + A background in clinical aspects of drug development , including all aspects of Medical Monitoring and study ... across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical,… more
- Bristol Myers Squibb (Princeton, 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …CMC (small molecules and biologics), biology, toxicology, clinical pharmacology, ADME/DMPK, early clinical development , etc. - Ability to create a ... **Senior Director , Early Development Team...**Senior Director , Early Development Team Lead** **Role Summary:**... Early Development teams to deliver early phase assets through clinical PoC, that… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …* Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development * Oversee clinical study timelines ... the program and development of best practices within CTM * Oversee clinical study budgets within a program: ensures review, presentation and approval of initial… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …for several serious illnesses with unmet needs in various stages of early development . This role will involve collaborating with cross-functional teams, ... disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical...closely with other key functions, including regional medical leads, clinical development , global value and real-world evidence,… more
