Senior Science Officer, Preclinical Development

CIRM•South San Francisco, CA

8d•Hybrid

About The Position

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. The Senior Science Officer will manage a portfolio of preclinical stage awards, advise grantees on experimental design, CMC development, and regulatory strategy, and support project progression towards key milestones. This role also contributes to the development and implementation of funding programs, fosters cross-functional integration with other teams (Clinical Development, Discovery, Patient Access, R&D Data Infrastructure), and engages externally to represent CIRM and identify emerging opportunities. The position requires a strong scientific background and experience in advancing therapeutic programs through preclinical development.

Requirements

PhD, MD or equivalent in relevant scientific discipline
Minimum 5 years of experience beyond doctoral degree, in preclinical/translational development in biotech, pharma, or academia
Demonstrated experience advancing programs through key preclinical and translational development milestones (IND-enabling stages), preferably in cell and/or genetic therapy
Strong understanding of preclinical development strategy, CMC and manufacturing considerations, and U.S. regulatory requirements and pathways for progressing therapeutic candidates toward IND submission and clearance
Experience critically evaluating scientific data, development plans, timelines and program risks across multiple therapeutic programs
Ability to identify and prioritize 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
Experience fostering a collaborative team environment by prioritizing shared goals, maintaining accountability, and supporting group decisions.

Nice To Haves

Direct experience participating in FDA meeting package preparation and in subsequent attendance at formal 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.
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 and data robustness, CMC development and manufacturability considerations, regulatory strategy and 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.