- Arcellx (Redwood City, CA)
- …a diverse set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs, you'll lead and drive Arcellx's ... Who We Are Arcellx isa public, clinical -stage biotechnology company reimagining cell therapy by engineering...Candidates with less experience may be considered at the director level. Proficiency directly writing submission documents that support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Sr. Director Data Management contributes to the vision, direction and strategy for Data ... Additionally, this position recommends and executes strategies in collaboration with Senior Management and global stakeholders that are optimized across business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3... team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- OM1 (Boston, MA)
- …allows us to generate unique insights in a variety of disease areas.The Director , Clinical Project Management works cross-functionally with the Epidemiology, ... are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our… 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 ... trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project ...and Clinical Study Reports (CSRs)/outputs throughout the project life cycle is optimized across multiple programs. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at a project level, and interacts with regional and global project team members, senior management, and outside vendors.Responsibilities:Responsible for all ... drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase... team members, and to a limited extent with senior management and outside vendorsMentors more junior department members,… more
- Merck & Co. (North Wales, PA)
- …Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Project Team to drive scientific decision-making both from non- clinical and clinical translational aspects, through close collaboration with ... translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing...and Japan, for a tight alignment with the Global Project Team. In addition, he or she will interact… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Oncology Drug Discovery Unit (ODDU) is looking for a Leader who will serve as Senior Director , Cell Engager Portfolio Lead reporting into the Solid and Heme ... projects moving from target identification and validation through early clinical proof of concept.This candidate will have a deep...or related field with 12+ years of industry experience.7 ( Director )-9 ( Senior Director ) years of… more
- Takeda Pharmaceutical (Boston, MA)
- …Oncology Drug Discovery Unit (ODDU) is looking for a Leader who will serve as Senior Director , Cell Engager Portfolio Lead reporting into the Solid and Heme ... projects moving from target identification and validation through early clinical proof of concept. This candidate will have a...related field with 12+ years of industry experience. 7 ( Director )-9 ( Senior Director ) years of… more
- Nova Anchora (Boston, MA)
- …from academic development into the clinic, we are seeking a highly skilled and experienced Senior Director of CMC to lead this critical phase of our journey. The ... IND filing in 2H2025 and start of phase 1 clinical studies shortly thereafter. Nova Anchora is supported by... Senior Director of CMC will play a… 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
- Rakuten Medical Inc. - US (San Diego, CA)
- Position Summary Reporting to the Chief Technology Officer, the Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating ... and mitigating risk of global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout.… more
- Dennis Partners (Boston, MA)
- …therapies for people living with serious muscle diseases. They are seeking a Regulatory Affairs Director or Senior Director who can develop and execute on ... communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management.Contribute to improvements in department… more
- Sedgwick Government Solutions (Bethesda, MD)
- Position Title: Director , Senior Executive Account Manager 2023-1315Location: Bethesda, Maryland, United StatesDepartment Name: Client ServicesJob Type: Full ... Managed Care Advisors (MCA)/ Sedgwick Government Solution's (SGS) high-profile account(s)?As a Director , Senior Executive Account Manager, you will lead a client… more
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