Jobs · Quality Assurance · California

Senior Science Officer, Preclinical Development

California Institute for Regenerative Medicine (CIRM) · South San Francisco, CA · 3 wk ago
HybridQuality Assurance$155k–$177k/yrFull-time

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)

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