- 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 ... trials and will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT Lead may be responsible for:-Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …biologic modalities. We collaborate closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, to ... Responsibilities include, but are not limited to: Work closely with the group Director to shape and execute strategy for biological characterization in all stages of… 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 ... specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… 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 ...the highest quality standards, with a focus on patient safety , data integrity, and regulatory compliance. Support internal and… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… 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 ... ready to make a difference? The Position The Scientific Global Medical Director will provide leadership, direction, and guidance for the development and… 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 ... Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the mission of our organization… 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 ... review of clinical components of key documents, clinical and regulatory documents, annual safety updates,...key documents, clinical and regulatory documents, annual safety updates, and registration dossiers (ie, protocol, ICF, IB,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... in order to accomplish objectives. Relationships Reports to the Executive Director , Patient Support Solutions. Key internal relationships include brand marketing,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …discussions at meetings and conferences Communication: Works with the Global Medical Director (s) to transform the clinical trial data into scientific and ... 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… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. **Summary** The Director , Clinical Safety , will be a product safety lead ... and/or epidemiology required. + Must have expertise in global clinical safety Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads...and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient scientific expertise… more
- Win (Women In Need) (New York, NY)
- …of care for high-risk clients in collaboration with Program Director to make clinical decisions regarding client care and safety . * Monitor and engage all ... Title of Position: Clinical Director (LCSW or LMHC) FLSA Status: Exempt Department: Transitional Housing Reports to: Program Director Positions reporting to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- ** Director , Clinical Development** **Join a Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of ... primary source of medical accountability and oversight for one or more clinical trials *Matrix management responsibilities across the internal and external network… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title** : Clinical Research Director **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed ... Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is… more
