Associate Director, Patient Access

Background

CIRM was created by the people of California to fund stem cell and gene therapy research with the goal of accelerating treatments for patients with unmet medical needs. With $8.5 billion in funding allocated through both Proposition 71 in 2004 and Proposition 14 in 2020 CIRM supports stem cell and gene therapy discoveries from inception through clinical trials trains a workforce in California to fill jobs in the states thriving biotech and biomedical research industry and creates infrastructure to make clinical trials accessible for people throughout California. All of CIRMs research workforce development and infrastructure programs are designed to benefit the people of California whose vision created the agency.

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. The PA Teams operational goal is to develop and manage clinical infrastructure programs to provide enhanced access to clinical trials and approved therapies for all Californians. CIRMs Clinical Infrastructure programs include: (1) the Alpha Clinics (AC) Network (2) the Community Care Centers of Excellence (CCCE) Network and the (3) the Patient Support Program (PSP). Additionally the PA Team serves as a bridge to policymakers and payers coordinating execution of CIRMs Access & Affordability strategy as well as coordinating CIRMs Accessibility and Affordability Working Group (AAWG) as outlined in Proposition 14.

Role Summary

The Associate Director serves as the primary strategic and operational lead for CIRMs Clinical Infrastructure Network (Network) which comprises the Alpha Clinics and Community Care Centers of Excellence. This role requires independent judgment cross-functional influence and deep subject matter expertise in clinical delivery of therapies clinical trial operations and clinical network infrastructure development.

The Associate Director is responsible for end-to-end leadership of Network build performance and continuous improvement ranging from funding program development and awardee management to coordinating multiple stakeholders for enhancing patient access to stem cell-based and genetic therapies. The Associate Director works directly with awardees internal CIRM teams and external partners to align Network operations with CIRMs broader portfolio goals and Access & Affordability Strategy. This role requires the ability to independently set priorities navigate complex operational challenges and drive solutions across a multi-site clinical infrastructure ecosystem in support of equitable patient access to stem cell-based and genetic therapies throughout California.

The Associate Director reports to the Associate Vice President Patient Access.

Job Functions

Manage the CIRM Clinical Infrastructure Network

• Lead the strategic vision and deployment of the CIRM Clinical Infrastructure Network to enhance patient access to CIRM-funded therapies.
• Lead Network Steering Committees including strategic planning governance coordination and accountability of network-wide deliverables.
• Identify and proactively leverage best practices across the Network to:
  • Accelerate contracting and launching of CIRM-funded clinical trials.
  • Enhance patient education engagement recruitment and retention in Network-supported clinical trials.
  • Facilitate professional training and specialization in clinical research and delivery of stem cell-based and genetic therapies in coordination with CIRM Education initiatives.
  • Ensure effective collaborations with community-based partner organizations in coordination with CIRM Community Engagement initiatives.
• Implement Network-wide standardized data reporting and evaluation of performance metrics to inform achievement of trial performance and patient access priorities.
• Manage a structured inquiry process enabling CIRM applicants and awardees to identify and connect with Network sites.
• Collect validate and track Network operational and clinical trial performance data to support infrastructure-wide improvements.

CIRM Program Operations & Reporting

• Ensure accurate timely and complete reporting of Network awardee activities in collaboration with CIRMs Grants Management Team.
• Develop manage and update individual Network awardee milestones to achieve program objectives.
• Prepare and present reports to internal and external stakeholders including Patient Access and CIRM leadership the CIRM governing board and the Access & Affordability Working Group (AAWG) on Network performance patient recruitment community engagement activities and emerging access considerations.
• Develop implement and maintain internal guidance documents workflows and Network SOPs that support standardized processes and cross-program collaboration.
• Maintain collaboration with CIRM Preclinical and Clinical Development Teams to proactively align Network operations with portfolio growth emerging trial needs and evolving program priorities.

Build and Expand the CIRM Clinical Infrastructure Network

• Coordinate the development and implementation of funding programs to enhance and scale the Clinical Infrastructure Network.
• Track and analyze trends in commercial cell and genetic therapy delivery across the Network to inform program development and Access & Affordability Strategy.

Stakeholder Engagement & Outreach

• Serve as the primary operational point of coordination between the Network CIRM teams CIRM awardees and external stakeholders.
• Lead the planning and execution of Network meetings workshops symposia and related patient & community engagement activities.
• Collaborate with CIRM Communications to support dissemination of Network information to statewide stakeholders as part of CIRMs Access & Affordability Strategy.
• Build and strengthen partnerships with external stakeholders including patient advocacy groups industry partners and community-based organizations to improve patient education & trial accessibility.

Harmonizing with the CIRM Mission

• Demonstrate commitment to CIRMs mission by advancing integrated equitable and patient-centered clinical infrastructure.
• Collaborate across teams to identify efficiencies enhance productivity and strengthen Network-wide access to CIRM-funded clinical trials and therapies.
• Support team and organizational decisions and contribute to achieving shared objectives under the Strategic Allocation Framework and Access & Affordability Strategy.

Supervision Received

The Associate Director Patient Access reports to the Associate Vice President Patient Access.

Supervision Exercised

None

Required Qualifications (Experience and Education)

• Bachelors degree in Public Health Business Administration Healthcare Management Economics Science or a related field relevant to clinical research program or clinical infrastructure management.
• Six (6) years of progressively responsible experience in managing clinical research leading/managing clinical trial operations and/or leading clinical network coordination in a healthcare or biotechnology environment.

Preferred Qualifications

• Advanced degree (Masters PhD PharmD MD etc.) is strongly preferred.
• Experience in the development or clinical delivery of cell therapies genetic therapies or other advanced therapy modalities is strongly preferred.

Competencies & Skills

• Excellent multi-stakeholder engagement and communication skills with experience interacting with patients community-based organizations advocacy groups public agencies healthcare providers and sponsors.
• Demonstrated experience with program planning implementation and evaluation.
• Proven cross-functional team coordination skills.
• Strong understanding of clinical trial infrastructure site readiness and patient navigation systems.
• Understanding of patient recruitment strategies including community-based outreach digital engagement and provider partnerships.
• Understanding of regulatory frameworks and compliance considerations in clinical research.
• Ability to be detailed organized and forward thinking with focus on anticipated trends challenges and opportunities.

Working Conditions

• Hybrid environment required to work two days in the South San Francisco office and currently 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.
• Some travel within State is required to visit CCCE and Alpha Clinic sites.

Salary Range and Benefits

This position is an exempt full-time role. The expected to pay for this position is $131544 -$203428
which fits within the full salary range of $131544 - $251328. 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.

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:

Director