- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will work across our gene ... with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions.… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and...is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will… more
- ThermoFisher Scientific (Greenville, NC)
- …biopharmaceutical company, all while maintaining full-time benefits. **Position Summary** The Director , Clinical Regulatory Affairs serves as a ... to regulatory RFIs to support timely trial startup and advancement. The Director , Clinical Regulatory Affairs partners closely with Clinical Operations,… more
- CSL Behring (King Of Prussia, PA)
- Associate Director , Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Associate Director , Corporate and External Affairs , R&D ... Relationships:** + **Reports to:** Head of Corporate and External Affairs , R&D + **Direct reports to position:** 1 **Main...and partners. + Serve as a key partner to regulatory policy team providing strategic counsel on advocacy opportunities,… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Partner across Kite Medical Affairs , Clinical Development, Translational Medicine, Regulatory Affairs , and Product Teams to build integrated cross-functional ... the lives of patients for generations to come. The US Medical Senior Director , MA Evidence Generation at Kite Pharma, a Gilead Company, will provide scientific… more
- CSL Behring (King Of Prussia, PA)
- The Director , Medical Affairs Statistics will support product marketing by generation of scientifically valid evidence that goes beyond the product label. The ... which at least 7 years of experience in Medical Affairs or other market facing organizations **Competencies** + Demonstrated...+ Ability to think out of the box of regulatory requirements + Familiar with causal inference based on… more
- Bristol Myers Squibb (Madison, NJ)
- …Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs , and other Cell Therapy Development ... QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions. + Supports the overall product quality… more
- CSL Behring (King Of Prussia, PA)
- The Director , Medical Field Team is a strategic leadership role responsible for leading and developing a team of 9-10 Medical Science Liaisons (MSLs) within a ... development of the MSL team and the effective execution of medical affairs priorities. People Leadership & Team Development * Directly manage, mentor, and… more
- Sanofi Group (Cambridge, MA)
- …Research Director , Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs , Biostatistics, Clinical Study Units, Medical Affairs ... **Job Title:** Development Scientific Director (DSD) **Location:** Cambridge, MA, **About the Job**...to the protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and… more
- Sanofi Group (Morristown, NJ)
- …Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge, MA **About the...experience in ophthalmology + Knowledge of drug development, ocular gene therapy, regulatory strategy + Good networking… more
- CSL Behring (King Of Prussia, PA)
- …field + 10+ years of experience in pharmacovigilance, safety data management, or regulatory affairs + Knowledge of global PV regulations, data standards (eg, ... therapies that make a meaningful difference worldwide. Could you be our next Associate Director , PV Standards and Governance? The job is in our King of Prussia, PA… more
- CSL Behring (King Of Prussia, PA)
- …cross-functional collaboration across the enterprise. Under the guidance of the Publications Director , you will partner with Medical Affairs leaders, Compliance, ... trackers, SOPs, and governance frameworks that ensure scientific integrity and regulatory compliance. You will also drive innovation in publication metrics and… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director , Commercial Data Science & AI is crucial in driving the overall strategy for (Gen)AI tools and technologies within CSL. This individual will ... role you will be reporting in to the Senior Director of Commercial Business Analytics Reporting & Data Science....use cases) In close partnership with ABCIA Commercial, Medical Affairs , and Market Access teams to ensure solutions are… more
- CSL Behring (King Of Prussia, PA)
- …data collection and submit all reports needed for compliance. 4. Work with Senior Director , Policy Advocacy & Government Affairs , & Legal to interpret and ... of biotech/pharmaceutical experience. **Experience** + Strong knowledge of the regulatory requirements for MDRP, Medicare/IRA, Veteran's Healthcare Act, and other… more
- University of Colorado (Aurora, CO)
- …trends and opportunities for improvement (OFI) through audits and occurrence reports to the Director of Regulatory Affairs and/or Quality Manager, which are ... fit for use. + Performs review of cell and gene therapy product files and sponsor protocols, ensuring accurate...- four (4) years of related quality assurance and regulatory affairs experience in a clinical laboratory.… more
- Sumitomo Pharma (St. Paul, MN)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of… more
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