- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... with the Global Team leader as the Project Management lead on drug development projects. This position... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional Medical Safety collaborations within and across line functions, eg Clinical Development , Medical Affairs, Regulatory Affairs, Clinical ... external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Medical, Clinical Development , Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of ... for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to… more
- Merck & Co. (Rahway, NJ)
- …hypothesis-based assessment employing a rigorous integrated approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical ... and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build... with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong… more
- Merck & Co. (Rahway, NJ)
- …a distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter ... state-of-the art scientific methodologies and tools to enable the discovery, development , regulatory approval, manufacturing, and marketing of medical drugs and… more
- Merck & Co. (Rahway, NJ)
- …The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or ... and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …record in executing effective project management in cross-functional drug development teams or clinical , regulatory, pharmaceutical sciences/technical operations ... for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position Title:** Clinical Development Program Lead , Hematology **Position ... Description:** The Clinical Development Program Leader (CDPL), Hematology sits within Clinical ...overall portfolio view + Provide strategic insights into the clinical development plans + Lead … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …(s) for Clinical Data Management (CDM). + Maintains an overview of clinical program (s) status and issues and proactively communicates progress, risks, issues ... The Program Data Management Lead is responsible for...if can:** + Acts as point of contact for clinical program and study level escalation. + Reviews… more
- Pfizer (New York, NY)
- … Clinical Study Group Lead , you will be an operational and clinical development leader accountable for delivery of your assigned portfolio comprised of ... Lead role, you will be responsible for talent development and supervision of Clinical Study Team...functional team leadership + Potential to work at the program /asset or study level if needed and assume CSTL… more
- Abbott (New York, NY)
- …of care. **What You'll Work On** The job purpose and scope of the Structural Heart Clinical Lead Specialist (CLS) is an integrated part of clinical trials ... full life. You'll also have access to: + Career development with an international company where you can grow...in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The **Senior Manager Clinical Study Lead ** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... large and/or complex clinical trials from study design, through execution, to study...the assigned study + Provides operational input into protocol development + Oversees and provides input to the … more
- IQVIA (Parsippany, NJ)
- …Clinical Training Manager or Associate Director will be responsible for the development and implementation of learning programs for clinical -based roles with ... ensure the delivery of business results. **Responsibilities** + Responsible for the development and delivery of aligned training, as well as, foundational and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... approved Safety Management Team (SMT) materials + Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs),...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development… more
- Atlantic Health System (Pompton Plains, NJ)
- Atlantic Health is Seeking a Gastroenterologist to Serve as a Clinical Lead at Chilton Medical Center Atlantic Health System, one of New Jersey's largest ... systems, is seeking a gastroenterologist to serve as a clinical leader for the new Center for Digestive Health...for Digestive Health at Chilton Medical Center. The Gastroenterology Program at Atlantic Health System is expanding, and we… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development - Respiratory Date: Dec 17, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 59023 ... people to make a difference with. **The opportunity** Director, Clinical Development is responsible for the ...documents for IND/NDA and other regulatory documents + May lead an NDA submission team independently, as needed +… more
- AbbVie (Branchburg, NJ)
- … studies and ensures scientific integrity and interpretation of study data of a clinical development program . Provides medical and/or scientific direction to ... Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Clinical Development will have global or regional responsibilities. Lead the… more
