Senior Officer, Patient Access

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 state’s 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 www.cirm.ca.gov .

General Statement

The Patient Access (PA) Team collaborates across CIRM’s core programs to foster innovative care delivery models and enhance the accessibility of regenerative medicine therapies. The PA Team’s operational goal is to enhance access to clinical trials and approved therapies for all Californians by coordinating clinical infrastructure networks, by supporting market access & patient access strategic planning for CIRM-funded therapies, and by advancing access and affordability research. Additionally, the PA Team serves as a bridge to policymakers and payers, coordinating execution of CIRM’s Access & Affordability strategy as well as coordinating CIRM’s Accessibility and Affordability Working Group (AAWG) as outlined in Proposition 14.

The Senior Officer, Patient Access will fill a critical role within the PA team by supporting CIRM-funded preclinical and clinical stage projects on stage-appropriate patient access and market access strategic planning activities. The role will develop and update patient access planning requirements for CIRM preclinical and clinical project funding programs, will be responsible for reviewing the progress of stage-appropriate planning activities, and will identify trends and opportunities for supporting enhanced patient access to CIRM-funded therapies. This role requires independent judgment, cross-functional influence, and deep subject matter expertise in development and execution of patient access and market access strategies for cell and gene therapies.

Implement Patient Access Planning Requirements

- Develop, implement, and maintain stage-appropriate patient access and market access planning requirements for CIRM-funded preclinical and clinical programs.

- Serve as a primary point of contact and subject matter resource for CIRM applicants and awardees navigating patient access planning requirements.

- Identify, recruit, and onboard leading experts to serve as reviewers for evaluating patient access planning components of CIRM grant applications and as external advisors for assess patient access planning progress across CIRM awards.

Support Patient Access Planning for CIRM-Funded Therapies

- Provide guidance to prospective applicants and current awardees on stage-appropriate patient access planning requirements, application expectations, and budget justification for access planning activities.

- Identify and curate resources, consultants, service providers, and best practices to support CIRM awardees in executing patient access and market access planning activities.

- Work closely with the Programs Teams to monitor and track progress of patient access, market access, and commercialization planning activities across CIRM's preclinical and clinical portfolio.

- Review and adjudicate patient access planning milestone reports and support Programs Teams’ approval of operational milestones and associated funding disbursements for preclinical and clinical stage awards.

- Collaborate with the Associate Director of Patient Access to facilitate use of CIRM's clinical infrastructure for enabling patient access to CIRM-funded therapies.

- Participate in Late-Stage Portfolio Management to track and support pre-commercialization and post-approval patient access activities for CIRM-funded therapies.

Conduct Portfolio-Level Analysis & Contribute to CIRM Strategy Execution

- Collate and analyze trends in patient access, market access, and commercialization strategies across CIRM's active portfolio.

- Track post-approval real world patient access to CIRM-funded therapies and benchmark against industry landscape

- Report portfolio findings and insights to the CIRM Access & Affordability Working Group (AAWG) to inform CIRM's overall Access & Affordability strategy.

- Collaborate with Patient Access Team leadership and the AAWG to identify gaps and additional resources needed to support patient access to CIRM-funded therapies.

- Support the Patient Access Team and AAWG in evaluating and advancing innovative financial and reimbursement models that promote affordability and sustainability of CIRM-funded therapies.

Establish Thought Leadership

- Routinely engage with payers, providers, patient advocates, health economists and therapy developers to maintain current knowledge and thought leadership on patient access and market access strategies.

- Monitor and analyze trends in payer coverage, reimbursement policy, and healthcare delivery relevant to cell and gene therapies to maintain current awareness and inform CIRM strategy and awardee support.

- Represent CIRM in scientific, industry, regulatory and policy forums.

Required Qualifications (Experience and Education)

- Bachelor’s degree in public health, Public Policy, Business Administration, Healthcare Management, Health Economics, Life Sciences, or a related field relevant development and commercial delivery of biologic drug products.

- Minimum 5 years of experience in the pharmaceutical or biotechnology industry, with direct involvement in development or executing strategies across re-commercialization planning, launch planning, market access, patient access, payer strategy, HEOR, government affairs or similar commercial roles.

Preferred Qualifications

- Advanced degree (Master’s, PhD, PharmD, MD, etc.) is preferred.

- Experience in clinical development, pre-commercial planning or commercialization of cell therapies, genetic therapies or other advanced therapy modalities is strongly preferred.

- Hands-on experience contributing to market landscape research, payer and reimbursement strategy development, payer engagement, identification of patient access challenges, patient support program development, health economic evidence generation and/or value communication is strongly preferred.

- Experience in a grant-making, advisory, consulting, or government agency role that involved evaluating, overseeing, or advising on market access or commercialization strategies is preferred.

Desired Skills/Abilities

- Excellent multi-stakeholder engagement and communication skills with experience interacting with patient advocacy groups, public agencies, private and public payers, healthcare providers and sponsors.

- Demonstrated experience with program planning, implementation and evaluation.

- Proven cross-functional team coordination skills across different functions such as market access, patient access, HEOR, medical affairs, and regulatory.

- Strong understanding of the diverse US therapy landscape including payers, providers, employers, reimbursement mechanics, care delivery economics, specialty pharmacy, buy-and-bill and barriers to patient access.

- Ability to effectively manage, organize and prioritize multiple projects and meet deadlines in a fast-paced and demanding environment.

- Understanding of regulatory frameworks and compliance considerations for commercial delivery of cell and genetic therapies.

- Ability to be detailed, organized and forward thinking with focus on anticipated trends, challenges, and opportunities.

- Strong written and verbal communication skills, including the ability to communicate complex technical and economic concepts to diverse audiences.

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.

Supervision Received

The Senior Officer, Patient Access reports to the Associate Vice President, Patient Engagement.

Supervision Exercised

None

Compensation

This position is expected to pay $121,946 - $165,462, which fits within the full salary range of $121,946 - $230,736 for the Senior Science Officer, II, Core Programs job classification. 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 leadership peer group.

Benefits

https://benefits.calhr.ca.gov/state-employees/

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  [email protected] .

Additional EEO Contact Information

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.