- Eisai, Inc (Exton, PA)
- …will also serve as a scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for the review ... and interpretation of analytical testing data as well as protocols and reports,...Since these programs are for products from pre-IND through phase 3, knowledge of the regulatory requirements at each… more
- Merck & Co. (Rahway, NJ)
- …first filing for oral development processes for human health while ensuring a phase appropriate approach during early development.In this role, the person will ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Merck & Co. (North Wales, PA)
- …skills: Deep clinical expertise in Rheumatology, Dermatology and Gastroenterology; building early phase plans and strategies; Customer expertise, especially of ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lead. Provide operational coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to ... on complex and/or late-stage project or act as main CMC Lead of an early -stage project. He/she has responsibility for the overall strategy and status of the project… more
- AbbVie (North Chicago, IL)
- …drug products for patients. The Director , Biologics ARD will lead the Analytical Development- Early Phase group within AbbVie's Lake County (North Chicago ... leadership and talent development for 10+ analytical scientists in Early Phase Analytical Development. + Adapt to changing environments and balances… more
- New York Medical College (Valhalla, NY)
- …and oversight of its teaching faculty. It is expected that the Clinical Module Co- Director will meet regularly with appointed Phase 1 Co-Directors. In addition, ... integration. Responsibilities + In collaboration with module's basic science co- director , relevant faculty, and phase 1 co-...motivate a group of diverse team members + Excellent analytical and problem-solving skills + Ability to role model… more
- BeiGene (San Mateo, CA)
- …and lasting impact on cancer patients **General Description:** This role will focus on early development ( phase I) and late stage ( phase II-III) safety ... science activities. The position has no direct reports. The Director Safety Scientist is part of a team that...+ Aggregate safety analysis with a particular focus on early development for Phase I, Phase… more
- Lilly (Indianapolis, IN)
- …for people around the world. #WeAreLilly **Organization Overview:** The **Associate Director - Analytical Operations and Compliance** will have responsibilities ... is comprised of experienced, creative, and energetic process chemists, analytical chemists, formulation scientists, and engineers who collaboratively contribute to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Translational Medicine (TM), will be primarily responsible for creating plans for ... early clinical development and implementing translational plans that are...and with external scientific experts. Reporting into the Senior Director of the Translational Medicine (TM) group, the … more
- Sumitomo Pharma (Columbus, OH)
- **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical ... diverse portfolio includes several marketed products and a robust pipeline of early - to late-stage assets. Building on Sumitomo Pharma's 125-year legacy of… more
- Sanofi Group (Cambridge, MA)
- **Senior Clinical Research Director , Early Development** The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages ... a team of Clinical Research Directors and Clinical scientists in Early Development I&I. The Sr CRD reports into the Head of Early Clinical Development I&I. The… more
- Lilly (Indianapolis, IN)
- …and knowledge in biologics CMC development and compliance requirements from early to late clinical phase programs. **Additional Skills/Preferences:** + ... part of a diverse team of biochemists, biologists, chemical engineers, and analytical chemists to develop Lilly's growing portfolio of therapeutic products and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and may contribute to candidate development projects through early and/or late phase development. The Associate Director reports to the Director , ... We are seeking a Associate Director to join out Oncology Clinical Development department....design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and… more
- Merck (Rahway, NJ)
- …at first filing for oral development processes for human health while ensuring a phase appropriate approach during early development. In this role, the person ... a range of modalities including small molecules and peptides. Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Lilly (Boston, MA)
- …for experienced and creative candidates to lead synthetic molecule development at the early phase interface with our Lilly Genetic Medicines (LGM) discovery team ... help accelerate programs and facilitate technical transfer to the early phase clinical supply team located in...ideas for future work plans. + Experience with modern analytical techniques and process analytical technologies (PAT).… more
- Bristol Myers Squibb (Devens, MA)
- …work effectively across functional groups and teams to ensure requirements are met (eg, early phase , late phase , regulatory). \#LI-Hybrid If you come across ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director (AD) Quality Product Lead (eg, QPL, Quality Product Steward)… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Oversees in-house GCLP infrastructure, systems and procedures to ensure adequate and phase -appropriate laboratory practices for analytical methods and testing in ... a related I/O field within a regulated environment + Experience with both early and late- phase clinical trial bioanalytical analysis + Proficiency with diverse… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …may contribute to candidate development projects through early and/or late phase development. Reports to the Director , Clinical Sciences Hematology, Clinical ... The Associate Director , Clinical Scientist leads in the development, evaluation,...design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Organization Overview:** The Sr. Director - TS/MS provides technical leadership for the of API External Manufacturing ... (API EM) portfolio. The Sr. Director TS/MS is responsible for interfacing with development scientists and teams to provide manufacturing guidance/feedback during the… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an Associate ... Director , Clinical Pharmacology and Pharmacometrics (CPP) to be located...for responding to regulatory authority queries. + Will drive early alignment on key development questions where CP principles… more
