Senior Director Preclinical Development

Background

The California Institute for Regenerative Medicine (CIRM) is a state agency created by California voters to accelerate stem cell and gene therapies for people with unmet medical needs. Since 2004 Californians have entrusted CIRM with $8.5 billion to accelerate promising discoveries through clinical trials train a regenerative medicine workforce strengthen the states biotechnology economy and expand access to transformative treatments. Today CIRM is pioneering new models of therapy development and accelerating medical breakthroughs that change lives in California and around the world. For more information visit .

General Statement

The Senior Director Preclinical Development provides strategic and operational leadership for CIRMs Preclinical Development (PDEV) programs. This role partners closely with the CSO to shape and execute the strategic direction of preclinical initiatives ensuring alignment with CIRMs 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 CIRMs preclinical development strategy aligned with CIRMs 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 CIRMs 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

• Establishstrong relationshipsand influence across allstakeholder levelsto enhance leadershipdirectionadvanceproblem-solving andimproveinterpersonal 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 CIRMs role as a leader in translational and preclinical development
• Establishes and implements short- and long-term Preclinical goalsobjectives policies and operating procedures.
• Providesstrategic guidanceleadershipand support to CSO.
• 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

Preferred

• Preferred 5 years in industry (biotech/pharma) in roles with direct responsibility for therapeutic development programs and team leadership
• Preferred 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 matrix 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

• 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 -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 $270000 - $300000 which fits within the full salary range of $241885 - $335467 for the Senior Director job 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 candidates qualifications experience skills knowledge relevant education and certifications in addition to being aligned with the internal leadership peer group.

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: Application Documents

Applicants must submit a resume and cover letter to be considered for this position.

Applicants requiring reasonable accommodations for the interview process should inform the interview scheduler at the time of scheduling.

Contact Information

For general questions regarding this position or inquiries specifically related to reasonable accommodations or Equal Employment Opportunity (EEO) please contact.

Additional EEO Contact Information

California Relay Service: 1- (TTY) 1- (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 creedsex (includes pregnancy childbirth breastfeeding and related medical conditions) and sexual orientation.

Required Experience:

Exec