Senior Science Officer, Preclinical Development

Senior Science Officer, Preclinical Development

The California Institute for Regenerative Medicine (CIRM) is a state agency created by California voters to accelerate stem cell and gene therapies for people with unmet medical needs. Since 2004, Californians have entrusted CIRM with $8.5 billion to accelerate promising discoveries through clinical trials, train a regenerative medicine workforce, strengthen the state’s biotechnology economy, and expand access to transformative treatments. Today, CIRM is pioneering new models of therapy development and accelerating medical breakthroughs that change lives — in California and around the world.

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The mission of the Preclinical Development team is to attract and rapidly advance the most promising stem cell‑based and genetic therapies through preclinical development into early‑stage clinical trials for diseases affecting Californians.

• Manage a portfolio of preclinical stage awards from early development through IND-enabling activities
• Ensure projects are aligned with CIRM’s mission, milestones, and timelines
• Identify scientific, technical, regulatory, and operational risks early and implement mitigation strategies

• Experimental design and data robustness
• CMC development and manufacturability considerations
• Regulatory strategy and IND-enabling requirements
• Stage-appropriate access strategy
• Support progression of projects toward key milestones (e.g., pre-IND, IND clearance, trial startup)
• Program Development & Execution
• Contribute to the development and implementation of funding programs that support preclinical development of stem cell‑based and genetic therapies
• Help define program scope, eligibility, and success criteria in collaboration with Review, Operations, and leadership
• Support continuous refinement of PDEV programs based on portfolio insights and field evolution
• Mentor team members in program design and applicant engagement
• Provide scientific and portfolio insights to inform continuous refinement of PDEV programs and funding strategies

• Collaborate with Clinical Development and/or external partners to facilitate transition of promising programs into clinical development
• Collaborate with Discovery to identify and shape high‑potential projects for translation
• Collaborate with Patient Access to incorporate early considerations of feasibility, delivery, and eventual patient access and impact
• Coordinate with R&D Data Infrastructure on data standards, DSMP expectations, and translational data quality
• Help break silos and ensure continuity across the full development pipeline
• External Engagement & Thought Leadership
• Represent CIRM in scientific, industry, and regulatory forums
• Engage with external experts, partners, and stakeholders to identify emerging opportunities and challenges
• Provide insight on ecosystem gaps (e.g., manufacturing, delivery, regulatory pathways, technology platforms)
• Contribute to shaping CIRM’s role as a leader in translational and preclinical development in regenerative medicine

• PhD, MD or equivalent in relevant scientific discipline
• Minimum 6 years of experience beyond doctoral degree, in preclinical/translational development in biotech, pharma, or academia
• Demonstrated experience advancing programs through key preclinical and translational milestones (IND-enabling stages), preferably in cell and/or genetic therapy
• Strong understanding of:
  • Preclinical development strategy
  • CMC and manufacturing considerations
  • Regulatory pathways (FDA, IND process)
• Experience evaluating scientific data, development plans, and program risks across multiple therapeutic programs
• Ability to identify scientific, technical, regulatory, and operational challenges and develop practical solutions
• Experience working in multidisciplinary and cross-functional environments
• Strong written and verbal communication skills, including the ability to communicate complex scientific concepts to diverse audiences
• Strong organizational, analytical, and project management skills

• Direct experience interacting with regulatory agencies…