Executive Director, Lifecycle Lead – New Technologies
Emeryville, California, United States of America
Full Time
17 hours ago
$275,000 - $310,000 USD
No Visa Sponsorship
Key skills
LeadershipProject ManagementStrategic Planning
About this role
Role Overview
Lead integrated asset strategy 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 pathways, platform investments, and lifecycle expansion strategies.
Partner with Research, Translational Sciences, and Clinical Development to enable seamless transition from discovery through development.
Provide strategic oversight of manufacturing readiness, including process characterization, tech transfer, PV/PPQ, comparability, and supply chain readiness.
Ensure alignment across Clinical Development, Manufacturing/MSAT & Supply, Quality, Regulatory, and Commercial teams for late-stage development and launch planning.
Guide commercialization strategy, including launch readiness, market access, product differentiation, and lifecycle expansion.
Partner with Project Management lead to develop and manage program timelines, action items, issues/risks and budget.
Support governance decisions on manufacturing strategy, CDMO partnerships, network design, capacity planning, and commercial supply.
Partner with Research, Translational Sciences, and Technical Development to advance next-generation therapeutic modalities and platform technologies.
Ensure development strategies reflect platform-specific regulatory, manufacturing, clinical, and commercial considerations.
Drive integrated multi-platform planning with focus on portfolio value and risk mitigation.
Lead cross-functional planning for INDs, BLAs, label expansions, post-marketing commitments, and global lifecycle management.
Work with third party technology and/or development partners to advance programs and operational plans
Requirements
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 vectors, 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 align cross-functional governance.
Success leading complex, cross-functional programs through major development and commercialization milestones.