Senior Manager, Community Care Centers of Excellence

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 the (2) Patient Support Program (PSP) and (3) the Community Care Centers of Excellence (CCCE). Additionally the group serves as a bridge to policymakers and payers coordinating CIRMs Accessibility and Affordability Working Group (AAWG) and Standards Working Group (SWG) as outlined in Proposition 14.

CIRM recently awarded $27 million through three grants across the state to create a network of CCCEs. The CCCE program is the first of its kind designed to make regenerative medicine clinical trials accessible for Californians who live far from major medical centers where most regenerative medicine clinical trials are conducted. The CCCE awards are designed to create hubs that expand the geographic reach of centers delivering clinical trials and approved regenerative medicine therapies extending access across California. Each center will also offer training and career development for both the delivery of treatments and wider patient support services required in the expanding field of regenerative medicine.

Role Summary

The Senior Manager serves as the operational lead for CCCE program implementation. The Senior Manager will work directly with awardees and internal CIRM teams to:

• Support end-to-end execution coordination optimization and continuous improvement of CCCE operations at individual sites consistent with established award milestones.
• Facilitate broader networking and connectivity across all PA programs to ensure the CCCEs function as a connected and interoperable component of CIRMs broader clinical infrastructure.
• Provide support to CIRM-funded pre-clinical and clinical programs utilizing the CCCEs.
• Engage relevant stakeholders (e.g. patients sponsors CCCE sites community members) to optimize program impact.

Operating under general direction the Senior Manager exercises sound judgment to set priorities manage workflows identify operational challenges and recommend solutions. The position reports to the Senior Director Patient Access and supports day-to-day program operations and execution while escalating strategic considerations as appropriate.

This position is classified as Senior Project Manager; however the working title is Senior Manager Community Care Centers of Excellence (CCCE).

Job Functions

Community Care Centers of Excellence (CCCE) Program Management

• Support operational planning and coordination for the CCCEs as part of an integrated statewide CIRM clinical infrastructure ecosystem.
• Serve as the primary operational point of coordination between the CCCE sites Patient Access Clinical Development Grants Management Communications Finance CIRM awardees and community-based organizations.
• Develop implement and maintain internal guidance documents workflows and CCCE-specific SOPs that support standardized processes and cross-program collaboration.
• Collect validate and track CCCE operational and clinical trial data; maintain program analysis documents dashboards and presentations that support infrastructure-wide visibility.
• Support the planning and execution of CCCE network meetings workshops symposia and related engagement activities.
• Align CCCE operations with Alpha Clinics and PSP infrastructure to enhance patient education and engagement improve trial recruitment and support seamless coordination referrals and handoffs to reduce barriers to patient access and enrollment.

Program Operations & Reporting

• Ensure accurate timely and complete reporting of CCCE activities in collaboration with CIRMs Grants Management team.
• Update individual CCCE award milestones or objectives in response to evolving needs or emerging evidence.
• Lead development of standardized performance metrics and dashboards across the CCCEs to evaluate equity patient engagement and clinical trial reach. Ensure transparency and accountability in CCCE activities.
• 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 CCCE performance patient referrals and recruitment community engagement activities and emerging access issues.

Process & Operational Improvement

• Support execution and continuous improvement of CCCE operations through hands-on collaboration with internal and external partners developing knowledge-sharing mechanisms to optimize CCCE operations and disseminate best practices.
• Identify and document risks gaps and inefficiencies that affect community engagement patient education & referrals enrollment or infrastructure coordination trial start-up and recommend process or operational improvements as appropriate.
• Coordinate sponsor and investigator inquiries facilitating meetings and cross-functional review to assess feasibility infrastructure readiness and network fit.

Stakeholder Engagement & Outreach

• Represent CIRM in meetings with clinical sites sponsors and external stakeholders to support shared understanding of how the CCCEs fit within CIRMs broader clinical infrastructure ecosystem.
• Engage with internal stakeholders to support transparency coordination and alignment across clinical infrastructure programs and clinical trial teams.
• Collaborate with CIRM Communications to support accurate and effective dissemination of CCCE information to community-based organizations and to the broader public as part of CIRMs statewide access 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 system-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 Senior Manager CCCEs reports to the Senior Director Patient Access.

Supervision Exercised

None.

Qualifications (Experience and Education)

• Bachelors degree in Public Health Business Administration Healthcare Management Economics Science or a related field relevant to program or clinical infrastructure management; Masters degree preferred.
• Six (6) years of progressively responsible experience in program support community or stakeholder engagement or clinical research in a healthcare or biotechnology environment.
• Experience in Cell and or Gene Therapy or other advanced therapy modalities is strongly preferred.

Competencies & Skills

• Excellent stakeholder engagement and communication skills with experience interacting with external stakeholders such as patients community-based organizations advocacy groups public agencies and the public to advance program objectives and report on outcomes.
• Demonstrated experience with health program planning implementation and evaluation. The ideal candidate will have experience developing and aggregating key program performance data / metrics to support performance evaluation and publishing / reporting results.
• Project management and coordination experience with multi-functional teams networks or consortia or CROs conducting scientific or biomedical research or implementing public health programs.
• Understanding of various recruitment strategies including community-based outreach digital engagement and provider partnerships.
• Knowledge of clinical networks health systems or the biotechnology industry.
• Experience in clinical research setting such as study coordination protocol oversight data management or patient care. Knowledge of the operational aspects of cell and gene therapy trials or treatments preferred.
• Ability to be detailed organized and forward thinking with focus on anticipated trends challenges and opportunities.
• Ability to professionally represent CIRM in internal and external engagements.
• Understanding of regulatory frameworks and compliance considerations in clinical research.
• Experience managing grant awards including progress reporting financial administration is a plus.
• Demonstrated ability to project manage multi-site initiatives.

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 $127308 - $143052 which fits within the full salary range of $127308 - $166668. 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:

Senior Manager