- 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
- 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
- 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
- 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. (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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join our Clinical Development team. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of ... of Clinical Scientists or Therapeutic area Lead Clinical Scientist and collaborates closely with Medical Director...and GCP guidelines as well as applicable SOPs regarding clinical safety + Promotes consistent first line… more
- WMCHealth (Valhalla, NY)
- Associate Director of Clinical Pharmacy Services Company: WMC Advanced Physician Services PC City/State: Valhalla, NY Category: Executive/Management Department: ... Pharmacy leaders to ensure that the department is optimized for quality, safety , and efficiency. The Associate Director collaborates with interdepartmental… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Development will play a key role in the Cardiovascular/Metabolism clinical development program within the Regeneron ... typical day in the life of a Senior Medical Director may include the following: * Leads clinical...Ensures safety of the drug, including the safety aspects of patients in clinical studies… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences, Oncology is a qualified physician scientist with exceptional academic clinical trials' experience, preferably in ... Oncology development. The Medical Director drafts designs of clinical study concepts...safety monitoring meetings. + Leads and supervises the Clinical Team to produce high quality program deliverables on… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Medical Director , Clinical Sciences, MASH/Metabolism works with their supervisor and other members of the cross-functional study team to author protocols and ... or inform the biology for decision-making purposes and enable clinical development programs. **As a Medical Director ,...ICH and GCP guidelines as well as SOPs regarding safety * Authors clinical sections of communications/documentation… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Medical Director , Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the ... program with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the...boards. + Supports Program Lead MD in ensuring overall safety of the compound in collaboration with the … more
