- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory strategic and ... limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic markets, regulatory strategic development… more
- Astellas Pharma (Northbrook, IL)
- …external stakeholders as a member of the asset team and leader of the clinical study team to advance one or more clinical trials. Serves as Medical Monitor w/ ... responsibility for safety monitoring. + Ensures patient safety on clinical study is maintained. Generates safety related documents, such as medical monitoring… more
- Bristol Myers Squibb (Seattle, WA)
- …This includes informing dose selection for Phase 1 through Phase 3 studies across various drug modalities and combination regimens, elucidating mechanisms of action, ... Independently design, implement, and interpret mechanistic models to support clinical study design, dose selection, and regulatory strategy * Engage external… more
- Bristol Myers Squibb (Princeton, NJ)
- …marketing authorizations across the globe. PCO is looking for a Scientific Director , Drug Metabolism to lead biotransformation activities in Development DMPK group ... with strategic planning, execution, and oversight of biotransformation and disposition studies in support of project and portfolio progression. + Independently… more
- AbbVie (North Chicago, IL)
- …years - Strong experience designing, overseeing, and interpreting GLP and non-GLP toxicology studies - Experience with regulatory submissions and interaction ... Safety (PCS) at AbbVie has an outstanding opportunity for a Director -level Board-Certified Veterinary Anatomic Pathologist. The successful candidate will lead the… more
- Lilly (Indianapolis, IN)
- …in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of biologics/antibodies. You will serve ... delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions. * Partner with… more
- Charles River Laboratories (Shrewsbury, MA)
- …services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and ... to meet revenue targets. Collaborate with clients and scientific staff for effective study design, problem solving, and delivery of high-quality study data.… more
- Catalent Pharma Solutions (San Diego, CA)
- …their objectives. + Provide direction for the development of drug CMC efforts including toxicology and human studies . + Communicate with clients with respect to ... **Title: Director Product Development** **About Catalent San Diego:** Catalent,...is seeking a dynamic leader to join us as Director , Product Development. The Director , Product Development… more
- Bristol Myers Squibb (Devens, MA)
- …of a company-wide approach to perform GLP environmental fate/effects studies and environmental risk assessments according to appropriate international regulatory ... on diverse multi-functional teams to deliver on-time and on-budget GLP studies and environmental risk assessments necessary to support successful clinical trials… more
- Abbott (Santa Clara, CA)
- …Our 114,000 colleagues serve people in more than 160 countries. ** Director , Biocompatibility** **Position Summary** Responsible for Biocompatibility support to the ... The position requires a Master or PhD degree in biology, biochemistry, toxicology , analytical chemistry or materials science, preferably with a specialism relating… more
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