- Merck & Co. (Boston, MA)
- …Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are properly trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully informed of the ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director , Global Clinical Operations on plans… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. Could you be our next Senior Director , Global Clinical Program Lead, Cardiovascular? The job ... clinical oversight and expertise during development of clinical studies ** **serves as medical monitor for...(CDP), the Project Strategy Document (PSD), Investigator Brochures (IB), Clinical Study Protocols (CSP), Informed Consent Forms… more
- Merck & Co. (North Wales, PA)
- …involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of ... monitoring, analysis, regulatory filing, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre- clinical and translational… more
- BeOne Medicines (Emeryville, CA)
- …ensure feasibility, study start-up, site management, drug supply and other clinical studies ' activities operating according to GCP and Health Authorities' ... for the planning, budget, and oversight the execution of clinical studies of BTU assets, through partnering...efficient study planning and execution of associated clinical programs/ studies + Conduct regular review meetings… more
- Arvinas (New Haven, CT)
- …evaluating, and presenting scientific and medical data, writing or providing content to clinical documents ( clinical study protocols and protocol synopses, ... to: ** Clinical Document Development** + Lead the development of clinical study protocol synopses and full protocols, including engage with subject matter… more
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Senior Director , HEOR is a strategic leader responsible for the development and ... of Insmed's gene therapy product(s) for intended indication(s). The Senior Director proactively engages and collaborates with...burden of illness studies , patient reported outcomes studies and clinical trial endpoint selection, disease… more
- Merck & Co. (South San Francisco, CA)
- …experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projectsAssist the Senior Director , Associate ... Job DescriptionThe Clinical Director (Principal Scientist) has primary...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Formation Bio (New York, NY)
- …and autonomous work environments Why Join Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical assets with real potential ... 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product… more
- Merck & Co. (Rahway, NJ)
- …therapeutic area and encourages appropriate application of new methods to HEOR studies .Maintains responsibility to ensure study conduct is aligned with company ... Job DescriptionThe Executive Director , Value & Implementation (V&I) Outcomes Research, position...as well as Outcomes Research.Under the guidance of a senior leader, this position leads a team of outcomes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, and Global Product Team to inform clinical ... up, model the way and enable the team to act.Provides medical leadership to:- GMA clinical operations teams as part of evidence generation forums and study teams… more
- Merck & Co. (Rahway, NJ)
- …our company Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports our company country ... Job DescriptionUnder the guidance of the Pneumococcal Vaccines Executive Director , Value & Implementation (V&I) Outcomes Research, the incumbent has the primary… more
- Merck & Co. (Philadelphia, PA)
- …our company Investigator Study Program Committee to evaluate outcomes research study protocols for studies in local markets.Supports our company's affiliates ... Job DescriptionUnder the guidance of an Executive Director , within the Value & Implementation (V&I) Outcomes Research team the incumbent has the following… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Merck & Co. (Rahway, NJ)
- …and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal ... strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s).Define design input(s)/ output(s)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director ... centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Merck & Co. (North Wales, PA)
- …in project area of interest or strong scientific background Understanding of the clinical development process, clinical study data and outcomes measures ... and medical communication agencies. With guidance and direction from the Director /Associate Director Publication Management, the Sr. Specialist Publication… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug… more
