Senior Director Preclinical Development

CIRMSouth San Francisco, CA
Hybrid

About The Position

The Senior Director, Preclinical Development provides strategic and operational leadership for CIRM’s Preclinical Development (PDEV) programs. This role partners closely with the CSO to shape and execute the strategic direction of preclinical initiatives, ensuring alignment with CIRM’s mission and long-term portfolio objectives. The Senior Director is accountable for driving cross-functional integration, advancing program priorities, and delivering measurable impact across the preclinical portfolio. CIRM is seeking an experienced and strategic scientific leader to serve as Senior Director of Preclinical Development (PDEV). This individual will lead the PDEV team and oversee a portfolio of early translational and preclinical programs, with the goal of advancing high-potential projects toward IND readiness. The ideal candidate will have deep expertise in preclinical and translational development of stem cell-based and/or genetic therapies, including IND-enabling studies, CMC development, and regulatory strategy. They will bring strong leadership and execution skills, with the ability to guide teams, manage complex portfolios, and work cross-functionally to accelerate development. This role is critical in ensuring that CIRM-funded preclinical stage programs are scientifically rigorous, operationally feasible, and positioned for successful clinical translation. The Senior Director reports to the Chief Science Officer (CSO). In this important position, the candidate will be interfacing with both internal and external stakeholders including the various CIRM groups such as other Programs teams (Discovery & Education, Clinical Development, and Data Infrastructure), Patient Access, Review, Grants Management, Legal, and Finance, as well as external grantees, patient advocates, and key opinion leaders.

Requirements

  • PhD, MD, or equivalent in a relevant scientific discipline
  • 10+ years of experience in preclinical/translational development in biotech, pharma, or academia
  • At least 5+ years in industry (biotech/pharma) in roles with direct responsibility for therapeutic development programs and team leadership
  • Minimum of 5+ years of direct people management experience, including hiring, performance management, and team development, with a track record of building high-performing, accountable teams
  • Demonstrated ability to lead in matrixed, cross-functional environments, driving alignment, accountability, and execution across teams
  • Demonstrated experience advancing programs through 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 managing complex therapeutic development programs and/or multidisciplinary teams
  • Strong problem-solving and decision-making skills in ambiguous, high-stakes environments

Nice To Haves

  • Direct experience interacting with regulatory agencies (e.g., FDA pre-IND/IND)
  • Experience working across academia and industry partnerships
  • Familiarity with challenges specific to regenerative medicine (e.g., delivery, comparability, potency, scalability)
  • Track record of leading or contributing to programmatic initiatives or funding programs

Responsibilities

  • Lead, manage, and prioritize the PDEV team, setting priorities, ensuring accountability, and fostering a high-performing, collaborative culture, with strong leadership skills focused toward a high-performance culture, while addressing organizational challenges which may arise.
  • Implement and direct execution of CIRM’s preclinical development strategy aligned with CIRM’s strategy.
  • Support the CSO in refining strategic plans for PDEV and translating strategy into actionable programs and outcomes
  • Provide high-level expert advice to the CSO and senior leadership, serving as a trusted thought partner on translational development, program direction, and strategic decisions
  • Acting as a subject matter expert (SME), providing expert guidance on translational readiness, IND-enabling pathways, and development risks across the CIRM preclinical awards portfolio
  • Contribute to organizational strategy discussions as a key member of cross-functional leadership groups, influencing decision-making and organizational alignment
  • Oversee the entire portfolio of preclinical and translational-stage awards from early development through IND-enabling activities
  • Manage a portfolio of preclinical and translational-stage awards from early development through IND enabling activities
  • Accountable for collective goals across the portfolio, driving performance, delivery, and impact across programs and stakeholders
  • Evaluate risks and implement corrective or alternative interventions, ensuring proactive management of scientific, technical, regulatory, and operational challenges
  • Ensure projects are aligned with CIRM’s mission, milestones, and timelines
  • As a SME, guide grantees on: Experimental design and data robustness, CMC development and manufacturability considerations, Regulatory strategy and IND-enabling requirements, Stage-appropriate access strategy
  • Support and accelerate progression of projects toward key milestones (e.g., pre-IND, IND clearance, trial startup)
  • Serve as a problem solver, applying structured thinking to complex development challenges and identifying practical, high impact solutions
  • Demonstrate the ability to tailor ideas into sound, scalable processes that support consistent execution across the portfolio.
  • Identify opportunities to collaborate with internal teams and external stakeholders to enhance program effectiveness, accelerate development, and expand impact
  • Establish strong relationships and influence across all stakeholder levels to enhance leadership direction, advance problem-solving and improve interpersonal communication on behalf of PDEV.
  • Lead and/or contribute to the development and implementation of funding programs that support preclinical development of stem cell-based and genetic therapies
  • Partner to 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, guide, and support team members in program design and applicant engagement to ensure high quality work performance
  • Accountable for working closely with Clinical Development to ensure seamless transition of preclinical programs into clinical stages
  • Ensure team alignment by clearly communicating priorities, establishing shared goals, and reinforcing accountability across functions and stakeholders
  • Partner 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
  • Establishes and implements short- and long-term Preclinical goals, objectives, policies, and operating procedures.
  • Provides strategic guidance, leadership and support to CSO.
  • As appropriate, present to and engage with the CIRM Board communicating program strategy, progress, and impact

Benefits

  • Information on benefits afforded by membership in the California Public Employees’ Retirement System can be found on the California Department of Human Resources (CalHR) Salary and Benefits website.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Ph.D. or professional degree

Number of Employees

5,001-10,000 employees

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