- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …PA or Somerset, NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Insmed Incorporated (NJ)
- …the future of science, we're in. Are you?About the Role:We're looking for a Senior Manager, Supplier Relationship Management on the Global Supply Chain & Logistics - ... expand what's possible for patients with serious diseases. Reporting to the Director , Supplier Relationship Management , you'll partner closely with Commercial and… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… more
- Amgen (Washington, DC)
- …statistical modeling for CMC development and commercial support. Reporting to the Senior Director , CMC Statistics, you will drive innovation in kinetic ... Join us and transform the lives of patients while transforming your career. ** Director , CMC Modeling & Advanced Statistics** **What you will do** Let's do this.… more
- Astellas Pharma (Northbrook, IL)
- …work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States ... regulatory frameworks and global CMC strategy. This role will lead the development and...partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- UTMB Health (Webster, TX)
- …evaluation or hospital transfers. If unsuccessful, elevates to department leadership and Senior Medical Director . Discharge Planning + Demonstrates skill in ... Utilization Review Case Mgr - CMC - Clear Lake Center **Webster, Texas, United...achieve target. + Presents LOS variances for review to Director and Inpatient Medical Director . Transfer Center… more
- UTMB Health (Huntsville, TX)
- Technical Supervisor, Lab Serv - CMC - Estelle **Huntsville, Texas, United States** Allied Health UTMB Health Requisition # 2505527 The mission of Correctional ... workflow for the division; and communicate with staff, management, and senior leadership. **_ESSENTIAL JOB FUNCTIONS_** **:** . Responsible for recruitment, hiring,… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Overview:** We are seeking a Senior Director , ADC Process Development, to lead and expand our growing team of ... project and program objectives. + Develop and implement short- and long-term CMC strategies to support a growing portfolio pipeline, while balancing internal and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to ... and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC , GRA-Devices, and regional regulatory scientists) and forms and maintains a highly… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- Otsuka America Pharmaceutical Inc. (Waltham, MA)
- **Job Summary** The Senior Director will serve as the Translational Medicine CNS Therapeutic Area Head, reporting to the VP, Translational Medicine and Early ... Clinical Development within OPDC's Early Development Organization (EDO). The Senior Director Translational Medicine will oversee a small team of CNS… more
- CBRE (Boston, MA)
- Senior Director - Agency Structured Transactions Job ID 232915 Posted 20-Oct-2025 Service line Advisory Segment Role type Full-time Areas of Interest Capital ... Borrowers and borrower counsel + CBRE producers, underwriters, and CMC groups **Ad Hoc & Strategic Projects** + Assist...education, training, and experience. The minimum salary for the Senior Director position is $150,000 annually and… more
- Takeda Pharmaceuticals (Boston, MA)
- …& Technology (DDT) portfolio driving innovation and operational excellence across the CMC lifecycle. This leadership role is accountable for shaping and delivering ... a product-driven agile culture to support delivery excellence + Collaborate with senior leaders across PharmSci, Research and RDDT including Business Partners, Tech… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a ... External Quality is currently seeking a leader at the Senior Director level to lead a team...Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality to achieve business… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Site Quality Head, Goa Date: Dec 1, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 63901 ... in accordance to cGMP requirements and registered specifications. + Most senior professional and independent decision maker authority on product quality and… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Director , Global Program Leader - Oncology, Solid Tumors in our Cambridge office. ... sub-teams, such as the Clinical Subteam, Commercial Subteam, Pharmaceutical Sciences ( CMC ) Subteam, etc. to the GPT through function-based subteam leaders to… more
