- Novo Nordisk Inc. (Plainsboro, NJ)
- …seeks to improve working procedures, quality , and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....needed. Relationships This position reports directly to the Executive Director , Clinical Development Strategy (CDS) and will… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and ... time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical ...FDA regulations, and other applicable regulatory requirements. Ensure that clinical trials are conducted to the highest quality… 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 ... CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high quality delivery of all studies for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing.... - Familiarity with Good Manufacturing Practices (GMP) requirements, quality procedures, and Standard Operating Procedure (SOP) execution. -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....you ready to make a difference? The Position Senior, Clinical Informatics leads the functions in the Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director , Quality Management Systems plays a pivotal role in ensuring ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...quality , safety, and efficacy of pharmaceutical products through the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... find better and more innovative ways to improve their quality of life. We're changing lives for a living.... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… 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 R&D ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… 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 R&D ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing… more
- Insmed Incorporated (San Diego, CA)
- …expertise with global counterparts in other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, ... Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Director , DSPV Gene Therapy Safety Lead will be the safety expert for… more
- Formation Bio (New York, NY)
- …in shaping innovative trial designs, supporting regulatory strategies, and ensuring high- quality statistical contributions across clinical development. They will ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...Bio is seeking a highly skilled and experienced Senior Director , Biostatistics to join our dynamic team. This critical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Executive Director (ED) for Field Medical Affairs in the US understands our Company's corporate and products/portfolio strategies and work ... and successfully in a highly matrixed environment is critical.The Executive Director provides strategic and tactical direction to the field Regional Medical… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Sr. Director , GMP Quality Assurance will lead the GMP QA strategy and ... as needed. Collaborate with cross-functional teams (eg, CMC, Regulatory Affairs, Clinical Operations) to ensure alignment on quality objectives, initiatives,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Director , Medical Communication and Publications will be an essential leader and responsible ... integral role in driving strategy development, planning, and execution of high- quality scientific publications across Genmab's Hematology portfolio. This role will… more
- Genmab (Plainsboro, NJ)
- …and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the medical oversight ... to preclinical development of candidate therapeutic antibodies. Drive and monitor quality of all clinical documents (eg, Investigators' Brochures, protocols,… more
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