- Novo Nordisk Inc. (Plainsboro, NJ)
- …We're changing lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... scientific contributions to integrate different approaches in modeling, statistics, and data science to bring value to the Eisai portfolio. This role requires… more
- Merck & Co. (San Diego, CA)
- …and biobanking. You will serve as a strategic partner to our discovery and clinical colleagues and will shape data science and AI/ML driven discovery strategies ... public data resources, to generate novel CDx models that can be deployed in clinical trials. You will also support preparation of regulatory documents in support of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Genmab (Plainsboro, NJ)
- …caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and ... fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible for leading the development and maintenance… more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head ... caring, candid, and impact-driven to our business, which is innovative and rooted in science , we believe that being proudly unique, determined to be our best, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the Executive Director , Medical Affairs and will assist the Executive Director and Senior Director (where applicable) in managing multiple internal ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical...for select clinical trials, in collaboration with Clinical Director and Clinical Operations… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of...the effective strategy, design, execution, and interpretation of Oncology clinical trials. Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… 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 ... ready to make a difference? The Position The Associate Director of Medical Data Strategy and Analytics plays a...extensive knowledge of the digital environment coupled with data science expertise to provide insights into the effectiveness &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CMC and other appropriate groups… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...Requirement:- BA or BS degree with an emphasis in science , health care or related fields.Preferred: Master's, PhD or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...internal stakeholders include Medical & Science , Clinical Operations, Regulatory Affairs, Data Management,… more
- Merck & Co. (Rahway, NJ)
- …represent the brand performance and agenda, priorities, and performance with senior level stakeholders for Small Molecule products across Global Pharmaceutical ... alignment and endorsement for supply chain strategic elements through senior stakeholder management and appropriate executive governance forums.Develop and maintain… 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 ... strategy, including integration of new technology platforms, human biology, and data science , with a focus on uncovering novel biology in immuno-metabolism to… more
