Senior Science Officer, Preclinical Development

CIRM•South San Francisco, CA

8d•Hybrid

About The Position

The California Institute for Regenerative Medicine (CIRM) is seeking a Senior Science Officer for its Preclinical Development team. This role is crucial for advancing promising stem cell-based and genetic therapies from preclinical stages through IND-enabling activities and into early-stage clinical trials. The team's mission is to accelerate the development of these therapies for unmet medical needs, aligning with CIRM's broader goal of transforming lives through regenerative medicine. The Senior Science Officer will manage a portfolio of awards, provide expert guidance to grantees, contribute to program development, and ensure seamless integration across the full development pipeline, from discovery to patient access.

Requirements

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, and 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.

Nice To Haves

Direct experience interacting with regulatory agencies (e.g., FDA pre-IND/IND meetings).
Strong knowledge of drug development, manufacturing process and regulatory for stem cell-based therapies and genetic therapies.
Proven track record of collaborating cross-team collaboration to deliver high-quality outcomes.
Ability to effectively manage, organize and prioritize multiple projects and meet deadlines in a fast-paced and demanding environment.
Outstanding communication skills.
Ability to work collaboratively in a team environment.
Ability to make clear, concise and impactful presentations.
Ability to embrace change and a desire to learn.

Responsibilities

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.
Advise grantees on experimental design, data robustness, CMC development, manufacturability, regulatory strategy, IND-enabling requirements, and stage-appropriate access strategy.
Support progression of projects toward key milestones (e.g., pre-IND, IND clearance, trial startup).
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.
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.