- 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 ... promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr . Director of Toxicology as part of the Clinical Development team… more
- 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 ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and… 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 ... thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person to create and influence strategy, assist with… more
- Organon & Co. (Plymouth Meeting, PA)
- …Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the ... Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... **Overview** The Director , CMC provides leadership for the...of regulatory submissions. + Experience with complex CMC regulatory submissions for both development 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 ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… 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 ... team. Join us and transform the lives of patients while transforming your career. ** Director , CMC Modeling & Advanced Statistics** **What you will do** Let's do… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience and/or immunology… 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)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Lilly (Indianapolis, IN)
- …and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the ... + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership skills with a… more
- J&J Family of Companies (Spring House, PA)
- …of America **Job Description:** Johnson & Johnson Innovative Medicine is recruiting for a ** Sr Director , Head of Data Science & Digital Health - Therapeutics ... discovery and clinical application, encompassing Chemistry, Manufacturing & Controls ( CMC ), Device Development, and Clinical Supply Chain. This organization ensures… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** **Head of Technical Development Data & Digital Team ( Senior Director )** We are seeking a highly motivated individual to ... join the Technical Development Strategy and Operations team as ** Senior Director of Data & Digital Team**...and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital… more
- ThermoFisher Scientific (Greenville, NC)
- **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Senior Director Project Mgmt - Oversight** At Thermo Fisher ... general medicine and vaccines. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Non-Interventional Oversight Team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director ,** **External Q** **uality Testing** **Operations** This role ... External Quality is currently seeking a leader at the Senior Director level to lead a team...functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC , and the wider Quality organization… more
- ThermoFisher Scientific (Greenville, NC)
- …gaining cross-cultural experience. **Discover Impactful Work:** We are seeking a ** Senior Director , Project Management** in our **Oversight Respiratory Trials ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic ... technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions. **Key Responsibilities:** **Tech Transfer Leadership** + Lead… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) ... development experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area + Knowledge of Global… more
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