- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and recruitment process, relationship management, training activities, and management metrics Lead development of commercial readiness strategy and oversees ... programs, and overseeing the management of speaker and HCP program operations and technology systems. This position will also... operations and technology systems. This position will also lead the development of operational business plans… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...ready to make a difference? The Position Serve as lead for CRM (customer relationship management) system supporting NNI… 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
- Bristol Myers Squibb (Princeton, NJ)
- …Responsibilities** + Collaborate with Clinical Science Program Lead and Clinical Development Lead to support development of clinical ... lifecycle planning + Lead implementation of assigned clinical development and/or lifecycle plans + Maintain...Maintain an advanced understanding of all protocols within assigned Program + Provide scientific and clinical leadership… more
- Novo Nordisk (Plainsboro, NJ)
- …KOLs and Principal Investigators. Essential Functions + Support the ALD clinical development program as medical lead and expert drug developer, providing ... the Senior International Medical Director will be the medical lead for clinical development of...Disease department. Work with the Clinical Operations, Non- Clinical Research, Medical Writing, Program Management, CMC… 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
- 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
