- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Global Clinical Development , Respiratory will focus on driving strategy, development , and life-cycle management ... new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and direct teams A minimum of 3 years in a supervisory role in clinical development /trials required We commit to an inclusive recruitment process and equality ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …Metabolism Section Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development , ... experience bringing drugs and leading teams through various stages of clinical development , with emphasis on late-stage developmentExperience with planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical ... if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical ... programs across different diseases and supervise the clinical development team. This individual will be the primary point person for medical monitoring and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will ... interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development , Medical, & Regulatory Affairs (CMR), Commercial Strategy &… more
- Merck & Co. (Rahway, NJ)
- …disorders. - The Senior Director will manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory ... and translational work for the purpose of generating early clinical development plan and Investigational new drug applications Developing clinical … more
- Merck & Co. (Rahway, NJ)
- …marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director ... will manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... and Product Development Team (PDT) Lead, Oncology Global Clinical Development , has primary responsibility for the planning and directing clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy: Drafts development plan… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... required; in a scientific discipline is preferred Minimum of 8 years of clinical development experience in the pharmaceutical industry with management experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building for the future, creating a distinct ... in a scientific discipline is required Minimum of 8 years of clinical development experience in the pharmaceutical industry At least 3-5 years of experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH,… 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)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... industry, regulatory agency or academia, with exposure to drug development , clinical pharmacology, and/or epidemiology required.Must have expertise… more
- Genmab (Plainsboro, NJ)
- …entire spectrum of drug development at Genmab, from Discovery to Late Clinical Development and beyond.The Head of Clinical Pharmacology & Quantitative ... the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies for Genmab's … more
- Novo Nordisk Inc. (Los Angeles, CA)
- …site management activities. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Merck & Co. (Rahway, NJ)
- …spend their first year in one of the following areas: (a) Global Clinical Development : Understand the role and methods of pharmaceutical research, participate ... equity, and inclusion objectives. The program provides in-depth exposure to clinical drug development with emphasis on key elements of clinical trial… 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 ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.)… more
- Genmab (Plainsboro, NJ)
- …drug supply strategic planning and execution, and maintain information on changing clinical development planIdentify risks for delays for projects/programs and ... compliance during all drug supply planning tasks, activities, and deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for… more
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