Senior Science Officer, Preclinical Development
Job Summary
The California Institute for Regenerative Medicine (CIRM) seeks a Senior Science Officer I to manage a portfolio of preclinical stage awards from early development through IND-enabling activities. The ideal candidate will contribute to the development and implementation of funding programs, collaborate with cross-functional teams, and represent CIRM in scientific forums.
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
- 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
- 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
- Contribute to shaping CIRM’s role as a leader in translational and preclinical development in regenerative medicine
Qualifications
- 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
Desired Skills/Abilities
- Direct experience interacting with regulatory agencies (e.g., FDA pre-IND/IND meetings)
- 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
Qualifications
- 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
Working Conditions
- Hybrid environment, required to work two days in the South San Francisco office and three days remotely
- Prolonged periods of sitting at a desk and working on a computer
- Must be willing to work in a high-rise building
- Ability to operate standard office equipment
- Occasional travel for work-related events
Supervision
- The Senior Science Officer I reports directly to the Senior Director of Preclinical Development.
- Exercised None
Compensation
This position is expected to pay $154,891 - $176,976, which fits within the full salary range of $154,891 - $207,480 for the Senior Science Officer job classification. It is uncommon for an individual to be offered a salary close to the upper end of the full range for a position. Salary for this position will reflect the final candidate’s qualifications, experience, skills, knowledge, relevant education, and certifications, in addition to being aligned with the internal leadership peer group.
Benefits
https://benefits.calhr.ca.gov/state-employees/
Required Application Documents
Applicants must submit a resume and cover letter to be considered for this position.
Additional EEO Contact Information
California Relay Service: 1-800-735-2929 (TTY), 1-800-735-2922 (Voice)