- Novo Nordisk Inc. (Plainsboro, NJ)
- …Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, and strategies Other essentials: ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. The CPM ... facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical ...protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate Collaborate with… more
- Insmed Incorporated (San Diego, CA)
- … of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervising the clinical ... will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of clinical studies, review &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) ... several programs . Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD functions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research 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. Serves as a primary source of medical accountability and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Publications, Medical Slides, and other related projects). Collaborate with Medical Director responsible for Communication Strategy and Medical Program ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs , ... areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… 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. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops ... function as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team, and US Product… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... for immuno-metabolic diseases and build a robust pipeline of drug discovery programs .Serve as a core member of the Discovery CMD leadership team.Implement the… more
- Merck & Co. (North Wales, PA)
- Job Description Role Summary: The US Regional Director Medical Affairs (RDMA) is responsible for driving execution of scientific & medical affairs plans for their ... members of regional cross-functional teams, including regional Commercial, Outcomes Research, Clinical Operations, Policy and Market Access. They engage with their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). 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 at Novo...programs , and Professional Associations/Public Affairs/Policy initiatives Work with Program Development and Training to support the overall strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non- clinical ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders.Job Summary Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the ... US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory… more
