- 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)
- …- Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/ medical standards in accordance with ethical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical...will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global… 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)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and global stakeholders, the Director of S&PE will establish the North America Clinical Development (NACD) strategy for the development and execution of ... About the Department The Clinical , Medical and Regulatory (CMR) department...experience P referred 5 years of team leadership in clinical development /trials Expertise in ICH-GCP principles and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical… 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)
- …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
- 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)
- 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)
- …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)
- …up Must have solid understanding of the pharmaceutical marketplace including legal, medical , regulatory and clinical processes Develops accurate short- and ... hard work and dedication with the opportunity for continuous learning and personal development . Are you ready to realize your potential? The Position Responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and develops clinical thought-leader relationships and involvement Leads in the development of plans and strategic marketing plans for new and current products ... part of the team, you will contribute to the development and delivery of our portfolio vision, business strategies,...and Board of Directors. Relationships Reports to the Sr Director Omnichannel Engagement. Responsible for the management of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... AEs, medical history, and medications when needed- Clinical Development Expertise Strategy- In collaboration with...from a medical strategy standpoint to the development of clinical sections of study-level documents… 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 ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... Interacts internally with Strategic Pricing & Contracting, Finance, Brands, Medical Affairs, HEOR, Commercial Pipeline, Field Sales, Account Management, Analytics,… 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
