Background

The California Institute for Regenerative Medicine (CIRM) is the state's Stem Cell Agency. We were created by the voters of California when they approved Proposition 71 in 2004, and renewed when Proposition 14 was approved in 2020, providing $5.5 billion to invest in stem cell research in California. CIRM's mission is to accelerate world class science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast-track the development of today's most promising stem cell and regenerative medicine technologies.

CIRM is the world's largest institution dedicated to helping people by bringing the promise of regenerative medicine closer to reality.

General Statement

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.

Key Responsibilities

Leadership of the Preclinical Development Function

• 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

Portfolio Oversight & Award Management

• 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.

Program Development & Execution

• 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

Cross-Functional Integration

• 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

External Engagement & Thought Leadership

• 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../li>
• As appropriate, present to and engage with the CIRM Board communicating program strategy, progress, and impact

Supervision Received

The Senior Director Clinical Development will report to the Chief Science Officer (CSO).

Supervision Exercised

The Senior Director Preclinical Development will manage and provide general direction to the Preclinical Development team.

Qualifications (Education, Experience, and Competencies)

Required:

• 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

Preferred

• 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

Key Attributes

• Strategic but highly execution-oriented
• Collaborative and able to work effectively across functions and stakeholders
• Clear and effective communicator, with the ability to translate complex science into actionable decisions, tailor messaging to diverse audiences, and drive alignment through effective upward and cross-functional communication
• Pragmatic and solutions-driven, with strong judgment in navigating trade-offs
• Mission-driven, with commitment to advancing therapies for patients

Working Conditions

• Hybrid environment, required to work two days in the South San Francisco office and three days remotely. In-person attendance of organizational meetings and board, subcommittee, and working group meetings as required.
• 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.
• Be available to work outside of normal business hours.

Compensation

This position is expected to pay $270,000 - $300,000 which fits within the full salary range of $241,885 - $335,467 for the Senior Director job classification. It is uncommon for an individual to be offered a salary near the maximum of the 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.

Required Application Documents

The following items are required to be submitted with your application. Applicants who do not submit the required items timely may not be considered for this job:

• Cover Letter detailing why the applicant is a good fit
• Resume/CV

For any inquiries about the position sent to [email protected], the e-mail should have the position title on the subject line.

Contact Information

Kathie Raftery

Email - [email protected]

Please direct requests for Reasonable Accommodations to the interview scheduler at the time the interview is being scheduled. You may direct additional questions regarding Reasonable Accommodations or Equal Employment Opportunity (EEO) for this position to CIRM's EEO Office.

EEO Officer:

Denise D'Angel

Email:[email protected]

California Relay Service: 1-800-735-2929 (TTY), 1-800-735-2922 (Voice) TTY is a Telecommunications Device for the Deaf and is reachable only from phones equipped with a TTY Device.

Equal Opportunity Employer

The State of California is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.

It is an objective of the State of California to achieve a drug-free workplace. Any applicant for state employment will be expected to behave in accordance with this objective because the use of illegal drugs is inconsistent with the law of the State, the rules governing Civil Service, and the special trust placed in public servants.

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.