- Genmab (Plainsboro, NJ)
- …for Genmab's first asset in hematology, EPKINLY. This critical role will report to the Director of Key Customer Strategy and be expected to work closely within ... best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director , Key Accounts will shape, implement, and execute Key Account brand… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA ... meetings.Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDALead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part of ... compound in late-stage development to implement the US regulatory strategy for multiple new indications. You will act as...cross-functional teams to ensure an optimal US regulatory submission strategy for the compound. You must have strong project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college ... or university)Bachelor's Degree requiredAdvanced degree (eg, Masters, Pharm.D., Ph.D., MD, JD) preferred Experience Qualifications7 or More Years in the pharmaceutical industry4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA Travel Ability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the ... Medical Affairs Leadership Team and serve as the voice for oncology within the department. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of NNI data assets and analytics content throughout key enterprise functions. The Director will set strategy , policies and guidelines for the appropriate use ... Director , Data & Analytics Governance reports to the Senior Director , Enterprise Data & Analytics Strategy . The role interacts on a regular basis with all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Executive/Senior Director of Value Communication and Contracting Strategy . Interacts ... potential? The Position Formulates, leads and executes the pricing and contracting strategy for a key Novo Nordisk product category. Collaborates with internal and… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Director of US Medical Affairs Solid Tumors Strategy will report to the Senior ... Director , US Medical Affairs Solid Tumors Strategy Lead. S/he will provide medical affairs leadership for...the development and execution of the US Medical Affairs strategy that is aligned with the company's goals and… more
- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are not ... limited to: Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile). For approved products, ensure that… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop ... compliance mindset and collaboration with various partners and stakeholders in development.The Director will report to the Executive Director of Biologics and… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy , lead activities, and develop a ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …E&C program based on industry trends and best practices. Relationships Reports to the Director , E&C Strategy & Operations. Works closely with the E&C Leadership ... hoc basis, including planning and execution of special projects Supports Director , E&C Strategy & Operations with E&C Program governance and associated special… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position This position supports the Ethics & Compliance (E&C) strategy by working with the Director , E&C Program Strategy & ... Inc. (NNI) and other North American affiliates. Relationships Reports to the Director , E&C Strategy & Operations. Works closely with the E&C Leadership team, NNI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... ResponsibilitiesProject Responsibilities: Independently manage or lead strategy development on Global Project Teams (GPT) for drug development projects in any phase… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in Corp. Functions so that they and Global DX develop a shared vision, strategy , and roadmap together from the beginning of discussion, and incorporate them into DX ... strategy .Advocation for business stakeholders and Global DX: Act as...ensure that technology solutions are aligned with the overall strategy and objectives of both the business and Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …this role will be responsible for shaping and managing GBD's engagement strategy with the external innovation ecosystem, internal stakeholder communication, and GBD ... GBD Stakeholder Communication and Strategic Engagement: Develop an external communication strategy in support of GBD priorities. This includes developing key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy , design, execution, and interpretation of Oncology clinical trials....medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product strategy based on a cross functionally designed strategy , as well as ... Project lead.ResponsibilitiesDevelop/propose (or have subordinates) integrated CMC product level strategy (manufacturing site selection for internal vs. external manufacturing… more
