- Genmab (Plainsboro, NJ)
- …with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. ... Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required...relevant. Support global regulatory lead and labeling strategy lead in development of the Company… more
- Genmab (Plainsboro, NJ)
- …organization.In this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the ... time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global ... the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...from a medical strategy standpoint to the development of clinical sections of study-level documents… more
- Genmab (Plainsboro, NJ)
- …current US and global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of commercialization.- For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. ResponsibilitiesStudy Strategy : Drafts development ... of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP),… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversees its tactical execution Oversees and leads pricing and contracting strategy , playbook, and guideline development for all new product launches ... Global Market Access to develop pricing scenarios and strategy for all pipeline products starting in Phase II...across the franchise Leads the optimization of the contracting strategy and roadmap development for the Commercial,… more
- Genmab (Plainsboro, NJ)
- …entire spectrum of drug development at Genmab, from Discovery to Late Clinical Development and beyond.The Head of Clinical Pharmacology & Quantitative ... CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety ... and compliance across clinical study safety reporting and activities. Global Management Strategy and Goals and Procedure Development : Assist Leadership to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and ... NJ. We support programs from early research through late-stage clinical development . We are building for the... Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Director, US Head GPM&L. ResponsibilitiesProject Responsibilities: Independently manage or lead strategy development on Global Project Teams (GPT) ... with the Global Team Leader in driving strategy development and ensures the execution of...drive the development and delivery of the clinical development plan in alignment with the… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development , Regulatory, and other ... development and execution of the US Medical Affairs strategy that is aligned with the company's goals and...expert in both internal and external venues including the US/ Global cross-functional teams, clinical development … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …specified therapy area preferred HCP marketing experience leading brand/therapy area strategy development and driving impactful customer experiences is required ... management and strategic collaboration HCP KOL marketing experience leading brand strategy development and driving impactful customer experiences is required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …learning cross functional roles and responsibilities such as (but not limited to) Clinical Development , Global Medical Affairs, Biostatistics, Clinical ... zones such as Japan. Education/Experience: o Express an interest in Leadership and Global Research and Development Drug Processes. Prior experience in project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the CMR organization. This individual ... will serve as a subject matter expect on clinical and medical informatics software and system development...strategy , portfolio, and product strategies as well as Global strategies. Drive understanding and appropriate use of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... support of new and approved drug products.Seeks and incorporate regional and functional RA strategy into a global strategy .Responsible for ensuring aligned … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead… more
