- Novo Nordisk Inc. (Plainsboro, NJ)
- …activities in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development . Internal relationships include ... About the Department The Clinical , Medical and Regulatory (CMR) department...Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within ... Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical ...Speakers' Bureau, including presentations at Speaker Training and Curriculum Development meetings Provide medical review of all… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department...SD works closely with the TA Leadership Team and Medical Director team to identify and execute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically… 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 ... of this position is to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …initiatives including but not limited to KOL development , advisory boards, clinical communications and medical education programs Responsible for the ... such things as in-depth market analysis, market research activities, thought leader development , HCP and patient marketing, medical education, sample planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead.Responsibilities: Medical Monitoring Planning (MD Only): For large Phase 2 or ... medical content for protocol profile, protocol and amendments for small, uncomplicated clinical studies; Directs CRO medical monitor activities for Phase 2… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sub-teams, Global Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Compliance, Finance, Clinical Development , Global Project Management, and Functional Quality ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...& Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team... Affairs projects within gynecological oncology indications.Responsibilities:- Leads the development and execution of the Global Medical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction ... of the Senior Director , GMA Oncology ADC (Global Medical Affairs...affairs projects within a specific compound or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups ... conduct of clinical trials is required Demonstrates technical expertise within Clinical Development , Medical Affairs, and Regulatory Affairs (CMR),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with global functions including but not limited to Commercial, Marketing, Medical , & Clinical Development ,ResponsibilitiesGlobal Market Access Strategy- ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...as with early-stage compounds required- Excellent understanding of the clinical development and life cycle of oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... script-based analysis packages to generate clinically relevant hypotheses to inform clinical development programsStay informed with emerging literature and… more
