- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational… 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
- Genmab (Plainsboro, NJ)
- …our purpose.Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & Pharmacovigilance Physician serves as the safety ... Regulatory AuthoritiesCollaborate with external experts and partners.Contribute to multidisciplinary project groups.Ensure compliance with regulatory guidelines and internal procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck & Co. (San Diego, CA)
- …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 ... clinical trials.- In addition, you will be the site...efficiencies to best execute on programs.Clearly communicate results to project teams, our company's scientific community, and the external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position ... and plans for assigned global projects. Gain endorsement from the Global Project Team (GPT) for these plans, ensuring appropriateness throughout the product's… 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 ... to handle both hands-on modeling and strategic leadership for a dynamic project portfolio and a strong track-record of scientific and collaborative leadership in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… 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
