Sr. Project Manager, Patient Access (Patient Support Program)

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, to accelerate world-class 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 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 Patient Access Team supports CIRM's mission by developing and managing programs that ensure that patients have access to innovative clinical trials and regenerative medicine treatments. CIRM recently launched a Patient Support Program (PSP) which provides logistical and financial support to patients participating in CIRM-funded clinical trials.

Role Summary:

The Sr Project Manager - Patient Access (Patient Support Program) (Sr PM (PSP)) will manage and oversee PSP operations while also collaborating closely with the CIRM Alpha-Clinics Network and the Community Care Centers for Excellence (CCCE) program to maximize patient access and streamline clinical trial support. This position requires financial oversight, managing contracts, and team coordination to keep funding and operations on track with CIRM's clinical infrastructure.

Job Functions

Patient Support Program (PSP) Management

• Manage and oversee PSP operations, ensuring high-quality service delivery through CIRM's external contractor (Eversana).
• Act as primary liaison with Eversana and other service providers to monitor program performance, identify gaps, and implement improvements
• Establish and maintain relationships with external vendor(s).
• Optimize costs to achieve the best value for CIRM & the patients it serves.
• Leverage project management tools and methodologies to monitor progress, improve efficiencies, and minimize issues.
• Lead budget oversight for the PSP program reviewing fund transfers from the Patient Assistance Fund, ensuring compliance with spending guidelines, and closely collaborating with finance to approve necessary adjustments.
• Coordinate the development, implementation, and refinement of Standard Operating Procedures (SOPs) for PSP execution and oversight.
• Support contract negotiations and renewals related to patient access and support services, ensuring alignment with CIRM's objectives and regulatory requirements.

Strategic Collaboration with Alpha-Clinics Network and CCCE Program

• Align PSP operations with Alpha-Clinics infrastructure to optimize trial recruitment and patient retention.
• Work with the Sr PM (PSP) (alpha-Clinics & CCCE Lead) to integrate PSP resources into Alpha-Clinics workflows, ensuring smooth patient navigation across sites.
• Develop training sessions and educational materials for Alpha-Clinics sites to increase awareness and utilization of PSP resources.
• Collaborate with the CCCE program to promote diversity and equity in clinical trial participation by leveraging PSP resources to address patient barriers.
• Participate in Alpha-Clinics Steering Committees and relevant working groups to provide insights into patient access trends and programmatic needs.

Program Operations & Reporting

• Develop and present reports to internal and external stakeholders, including CIRM leadership and the governing board, on PSP performance, patient demographics, and financial sustainability.
• Oversee data collection and quality control, ensuring accurate and timely reporting of patient support metrics.
• Manage contract compliance for patient support initiatives, tracking vendor deliverables and ensuring adherence to regulatory and financial requirements.
• Support CIRM's patient-facing digital platforms, including the clinical trials dashboard, ensuring accessibility and user-friendliness for patients seeking trials.

Stakeholder Engagement & Outreach

• Facilitate cross-team collaboration between PSP, Alpha-Clinics, CCCE, and the broader CIRM clinical network to harmonize patient access efforts.
• Engage with external stakeholders, including patient advocacy groups and industry partners, to explore opportunities for expanding PSP capabilities.
• Represent CIRM at community engagement events, patient forums, and industry conferences to promote awareness of patient support initiatives.

Harmonizing the CIRM Mission

• Demonstrating in your words and actions commitment to CIRM's mission.
• Collaborating with CIRM team members to generate efficiencies, enhance productivity, and develop competencies.
• Committing to team decisions by supporting and working to achieve team objectives.

Supervision Received

The Sr PM (PSP) reports to the Associate Director of Patient Access.

Supervision Exercised

None

Qualifications (Experience and Education)

• Bachelor's degree in Public Health, Business Administration, Healthcare Management, Economics, or a related field required; Master's degree is preferred.
• Preferred minimum of 6 years of experience in patient support programs, clinical trial logistics, healthcare operations, or a related field.
• Preferred 5 years of experience in financial oversight, program budgeting, or fund allocation management in a healthcare or biotechnology setting.

Desirable Skills and Abilities

• Experience managing vendor contracts and financial compliance, including budget forecasting, expense tracking, and contract negotiation.
• Demonstrated leadership in strategic program implementation, including cross-functional coordination between patient access programs and clinical trial networks.
• Experience working with clinical networks, health systems, or the biopharmaceutical industry in the development of patient access solutions.
• Ability to analyze program performance, develop process improvements, and implement best practices for operational efficiency in a regulated healthcare setting.
• Proven ability to navigate legal and regulatory compliance related to patient support programs in healthcare or biotechnology.
• Strong experience in stakeholder engagement, including presenting complex programmatic and financial data to leadership, external partners, and regulatory bodies.
• Experience leading operations within a biotech, pharmaceutical, or large healthcare organization, overseeing patient access programs or financial resource management.
• Familiarity with large-scale clinical trial networks (e.g., Alpha Clinics) and patient recruitment strategies for investigational therapies.
• Advanced knowledge of health economics, insurance reimbursement models, or payer negotiations.
• Proficiency in contract negotiations, vendor oversight, and financial auditing to ensure compliance with state and federal regulations.
• Strong analytical and problem-solving skills with the ability to manage multiple projects.
• Excellent communication skills.
• Project management skills in planning, executing, and stakeholder coordination.

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.

Salary Range and Benefits

This position is expected to pay $127,308 - $144,504 which fits within the full salary range of 127,308 - $161,813. It is uncommon for an individual to be offered a salary close to the upper end of the full 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 peer group.

Required Application Documents

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

• Cover Letter
• Resume/CV

For any inquiries about the position sent to jobs@cirm.ca.gov, the e-mail should have the position title on the subject line.

Contact Information

Kathie Raftery

Email - jobs@cirm.ca.gov

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:jobs@cirm.ca.gov
• 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.