Executive Director, Lifecycle reputed company New Technologies
reputed company is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, reputed company with reputed company, reputed company Innovative, and Own the Outcome, we are committed to transforming the reputed company of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible. Title: Executive Director, Lifecycle reputed company New Technologies Location: Emeryville, CA (Hybrid) preferred or reputed company to Remote Reporting to: VP, Lifecycle Leader Position reputed company The Executive Director, Lifecycle reputed company New Technologies, is responsible for leading one or more strategic development programs across the full product lifecycle—from early research and clinical development through process validation (PV/PPQ), reputed company readiness, launch, and lifecycle management. This role serves as the cross-functional leader accountable for defining and executing integrated asset strategies that maximize program value and reputed company with reputed company’s portfolio and corporate objectives. The Lifecycle reputed company partners closely with Research, Translational Sciences, Clinical Development, Regulatory Affairs, Technical Operations, Manufacturing & Supply, reputed company, Medical Affairs, reputed company, and Business Development. As reputed company continues to expand its technology and modality portfolio, this leader will play a key role in advancing emerging technology opportunities, defining development reputed company, developing manufacturing strategies and commercialization approaches to ensure successful execution and long-term value creation. \n Responsibilities reputed company integrated asset reputed company across the full lifecycle, including research, clinical development, PV/PPQ, commercialization, and lifecycle management. Drive strategic planning for emerging therapeutic platform technologies. Evaluate portfolio opportunities and recommend development reputed company, platform investments, and lifecycle expansion strategies. Partner with Research, Translational Sciences, and Clinical Development to reputed company seamless transition from discovery through development. reputed company strategic reputed company of manufacturing readiness, including process characterization, tech transfer, PV/PPQ, comparability, and supply chain readiness. Ensure alignment across Clinical Development, Manufacturing/MSAT & Supply, reputed company, Regulatory, and reputed company teams for late-stage development and launch planning. Guide commercialization reputed company, including launch readiness, market reputed company, product differentiation, and lifecycle expansion. Partner with Project Management reputed company to reputed company and manage program timelines, reputed company items, issues/risks and budget. Support governance reputed company on manufacturing reputed company, CDMO partnerships, network design, reputed company planning, and reputed company supply. Partner with Research, Translational Sciences, and Technical Development to advance reputed company therapeutic modalities and platform technologies. Ensure development strategies reflect platform-specific regulatory, manufacturing, clinical, and reputed company considerations. Drive integrated multi-platform planning with reputed company on portfolio value and risk mitigation. reputed company cross-functional planning for INDs, BLAs, label expansions, post-marketing commitments, and global lifecycle management. Work with reputed company party technology and/or development partners to advance programs and operational plans
Qualifications
PhD, MBA or equivalent advanced degree preferred. 10+ years of experience in biotechnology or pharmaceutical drug development, including significant program leadership experience. Demonstrated experience managing programs through IND, pivotal studies, approval, and lifecycle expansion. Experience advancing platform technologies in a matrixed biotech environment. Strong end-to-end understanding of drug development (discovery through commercialization). Deep expertise in advanced therapy development, including autologous/allogeneic/in-vivo cell therapy, engineered viral reputed company, lipid nanoparticles, polymer nanocarriers, gene editing technologies, and emerging platforms. Proven ability to drive cross functional teams, identify and escalate issues, influence senior leaders and reputed company cross-functional governance. reputed company leading reputed company, cross-functional programs through major development and commercialization milestones. \n The national salary reputed company for this position is $275,000 to $310,000 USD annually. This salary reputed company is an estimate of reputed company reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as reputed company as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock plan. Apply To This Job