- 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
- 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)
- …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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during ... scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process … more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during ... scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process … 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
- 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
- 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …Read more: careers.bms.com/working-with-us . **Functional Area Description** The Early Development Clinical Scientist function provides scientific expertise ... to clinical scientists on study team (matrix leadership). + May support clinical development planning in collaboration with Early Clinical Development… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … studies and ensures scientific integrity and interpretation of study data of a clinical development program . The Director leads in a matrix environment ... The Director Clinical Sciences, Hematology, leads in the development...day may include the following:** + May function as lead Clinical Scientist (CS) for program… more
- Bristol Myers Squibb (Madison, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... work and in their personal lives. Read more: careers.bms.com/working-with-us . **Senior Clinical Trial Physician, (Late Clinical Development , Cell Therapy,… more
- Lilly (Branchburg, NJ)
- …degree + At least 5 years work experience in supply chain management or clinical development **Additional Preferences:** + Experience with SAP + Intermediate to ... will be responsible for driving robust, strategic discussions across Clinical Capability and Clinical Design Development...portfolio analyses through robust data and metrics analysis + Lead and ensure operational excellence in Clinical … more
