Senior Director Patient Access

Background

The California Institute for Regenerative Medicine (CIRM) is the states 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. CIRMs mission to accelerate worldclass science to deliver transformative regenerative medicine treatments in an equitable manner to a diverse California and world is what drives us to succeed every day.

To meet this challenge our team of highly trained and experienced professionals actively partners with both academia and industry in a handson entrepreneurial environment to fasttrack the development of todays most promising stem cell and regenerative medicine technologies.

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

General Statement

The Patient Access (PA) Team collaborates across CIRMs core programs to foster innovative care delivery models and enhance the accessibility of regenerative medicine therapies. This team develops and manages clinical infrastructure programs such as the Alpha Clinics Network Community Care Centers of Excellence and the Patient Support Program. Additionally the group serves as a bridge to policymakers collaborating with CIRMs Affordability and Accessibility Working Group (AAWG) and Standards Working Group (SWG) as outlined in Proposition 14 and supports other policy functions.

Clinical Infrastructure Support:

• CIRM Alpha Clinics Network: A network of nine California medical centers dedicated to delivering cell and gene therapy (CGT) clinical trials.
• Community Care Centers of Excellence: Launching in 2026 these centers will work alongside the Alpha Clinics to expand access to clinical trials.
• Patient Support Program:Provides logistical and financial support to patients participating in CIRMfunded clinical trials.

Policy Advisory Group Support:

• Access and Affordability Working Group (AAWG): Provides recommendations to develop and implement financial models that enhance the accessibility and affordability of treatments and cures from CIRMfunded research and supports the deployment of $90M AAWG research budget.
• Scientific and Medical Accountability Standards Working Group (SWG): Advises on scientific medical and ethical standards for CIRMfunded research.

Role Summary

This Senior Director of Patient Access will lead and manage this team in coordination with CIRMs policy working groups (AAWG and SWG) and coordinating with the Chair of the AAWG. The Senior Director will report to the CIRM Chief Science Officer (CSO) who will ensure CIRM internal resources and authority are available to achieve the teams objectives and are integrated within the overall scope of CIRMs mission and goals.

Job Function

• Provide leadership and oversight of CIRMs Patient Access team fostering a collaborative culture of highperformance and ensuring crossfunctional alignment to advance access and affordability of CIRMfunded therapies.
• Oversee the deployment and management of CIRMs Clinical Infrastructure Programs to achieve the strategic goal of ensuring referral enrollment and retention of patients in clinical trials.
• Support the development of market access and reimbursement strategies (in consultation with the AAWG and collaboration with the Clinical Development and Preclinical Development teams) for CIRMfunded clinical research programs.
• Propose and lead research and advocacy initiatives that advance access and reimbursement for regenerative medicines.
• Develop strategic policy initiatives related to patient access reimbursement strategies and postmarket research in close coordination and collaboration with the Chair of the AAWG.
• Support CIRM broadly in building state and national partnerships and engagement strategies to expand access to regenerative medicines in collaboration with the Chair of the AAWG.
• Lead and participate in the analysis and interpretation of patient access data assisting in the preparation of reports policy briefs and advocacy materials.
• Collaborate with the CSO and all CIRM groups/functions to deliver timely completion of activities related to patient access and community engagement programs.
• Work closely with CIRMs Clinical Development Team and Preclinical Development Team to integrate patient access efforts and support the success of CIRMfunded clinical trials.
• Lead the development and refinement of policies and resources for data management and data sharing to support patient access and postmarket initiatives.

Supervision Received

The Senior Director Patient Access reports to the Chief Science Officer (CSO) of CIRM.

Supervision Exercised

The Senior Director Patient Access will manage and provide general direction to the Patient Access team.

Qualifications (Experience and Education)

• MD PhD or PharmD or Masters degree in Public Health may be considered in lieu of doctoral degree provided the candidate has at least 2 additional years of relevant experience in healthcare delivery and coverage policy.
• 10 years in a senior leadership role within healthcare policy biotech/pharma industry patient access or market access with a demonstrated ability to navigate complex policy landscape.

Competencies & Skills

• Proven track record in managing and leading teams to deliver highquality outcomes.
• Experience managing multisite clinical infrastructure and scaling implementation in complex healthcare environments.
• Good understanding of clinical trial site readiness network coordination and integration of advanced therapy systems.
• Practical experience in budgeting grants management and resource planning for largescale clinical initiatives.
• Expertise in healthcare economics valuebased payment models and reimbursement strategies.
• Strong background in policy advocacy and coalition building with experience working with governmental bodies and policymakers at both state and federal levels; adept at engaging internal and external stakeholders across a range of policy areas including social drivers of health and payment reform.
• Experience with rare diseases and patientcentered care models.
• Strong track record of interactions with the FDA CMS and commercial payers with deep familiarity with regulatory decisionmaking healthcare data medical product development and marketing; wellversed in regulatory frameworks and the use of RealWorld Data/Evidence in FDA and CMS interactions.

Working Conditions

• Hybrid environment required to work two days in the South San Francisco office and currently three days remotely. Inperson 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 highrise building
• Ability to operate standard office equipment
• Be available to work outside of normal business hours

Salary Range and Benefits

This position is expected to pay $270000 $300000 which fits within the full salary range of $241885 $335467 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 candidates qualifications experience skills knowledge relevant education and certifications in addition to being aligned with the internal leadership peer group.

Required 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.

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

Benefits

EEO Contact Information

California Relay Service:(TTY)(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.