Senior Science Officer, Preclinical Development

CIRM•South San Francisco, CA

9d•$154,891 - $176,976•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, Preclinical Development will manage a portfolio of preclinical stage awards, ensure projects align with CIRM’s mission, identify and mitigate risks, and advise grantees on various aspects of development. This role also contributes to program development, cross-functional integration, and external engagement. Key responsibilities include managing a portfolio of preclinical awards, ensuring alignment with CIRM's mission and timelines, identifying and mitigating risks, and advising grantees on experimental design, CMC, regulatory strategy, and access strategy. The role supports project progression towards key milestones and contributes to the development and implementation of funding programs. Collaboration with Clinical Development, Discovery, Patient Access, and R&D Data Infrastructure is essential for seamless pipeline progression. The Senior Science Officer will also represent CIRM in external forums, engage with stakeholders, and contribute to CIRM's leadership in translational and 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
Strong understanding of CMC and manufacturing considerations
Strong understanding of 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
Advise grantees on CMC development and manufacturability considerations
Advise grantees on regulatory strategy and IND-enabling requirements
Advise grantees on 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