- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Medical Director is a key leadership role and will develop, ... a franchise approachProvide key strategic input into publication planning and review , medical backgrounders, FAQ and standard responses, internal training… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead ... evolve product data generation plans and ensure there is OneMedical strategy Review publications, help create medical backgrounders, FAQ and standard responses,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the ... the VP Medical /Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …any time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk...responsible for administrative and management support of field-based FMA Program at Novo Nordisk Inc (NNI). Accountable for ensuring… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Development Strategic Initiatives will work with the Chief ... focus will be to refine and further develop the Clinical Protocol Review Committee for the Global Clinical Development organization that will include Phase… more
- Insmed Incorporated (Bridgewater, NJ)
- …area.Develop and maintain strong partnerships for external interactions with the investigators, medical experts, payers, review boards, etc.Manage and mentor a ... in search of a passionate leader for the role of Biostatistical Head of Medical Affairs. This position, reporting to the VP of Biometrics presents a unique… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of the ... Key Performance Indicators (KPIs). This role works closely with the Clinical Program Operations Leads, Clinical Trial Managers/Leads (US & Europe), Clinical Business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs team lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select Medical Affairs ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning...with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of… more
- Merck & Co. (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs ... development activities (eg engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... research areas centered around rare diseases and immune disorders.Summary The Associate Director , Privacy & Compliance Investigations, is a member of the Compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs team lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs ... research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major scientific/ medical contributor; For large or complex Phase 2 studies: Provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...against trial progress and bring deviations to the Operational program Lead and study team leader. Review … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay… more
- Insmed Incorporated (Bridgewater, NJ)
- …Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information included in ... on all the clinical aspects of the upcoming HS program . Strong leadership skills are a must for this...and responses to questions from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coding of AEs, medical history, and medications when needed- Addresses medical questions directly from sites/ Institutional Review Boards (IRBs), and other ... Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing eligibility and medical questions from sites/… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively...team to develop safety strategy, key safety messages, and review and author safety sections of Common Technical Document… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development, maintenance, ... internal and external stakeholders. Proven experiences in Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the… more
