Director / Senior Director, Head of Patient Access & Reimbursement

Stellenbeschreibung:

About the Company

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome‑based therapies for rare diseases. Our lead product, Deramiocel (CAP-1002), is in late‑stage development for Duchenne muscular dystrophy. We also leverage our proprietary StealthX™ exosome platform for targeted delivery and vaccinology. We are committed to pushing the boundaries of science and delivering life‑changing treatments to patients and families.

Role Overview

The Director/Senior Director – Patient Access & Reimbursement will engage with key stakeholders and external vendors to ensure seamless patient access of Capricor’s approved therapies. The role builds a strategic partner team responsible for timely site activation, operational readiness, and delivering patient access and reimbursement services. The field team will manage patient referrals, product distribution, patient affordability, operational processes, and patient/caregiver engagement.

Essential Functions / Responsibilities

Serve as a strategic leader to build and lead a regionally aligned Patient Access & Reimbursement field team.
Hire, onboard, facilitate training of the field team.
Develop the field‑based role and ways of working in partnership with Cross‑functional Commercial leadership.
Develop a field‑based patient access team that serves as the strategic partner to HCPs and sites of care, delivering billing and coding reimbursement education to support patient access journey for DMD families.
Establish access goals, productivity measures, and ensure account plans are created and executed quarterly / annually.
Work collaboratively with cross‑functional teams, including Commercial Operations, to monitor patient scripts through the fulfillment process.
Partner with the Patient Services lead to ensure timely identification of access issues and resolution.
Create an environment of ongoing learning and development for the field‑based team.
Work collaboratively with Trade and Patient Services functional leaders to identify process efficiencies with third‑party service providers.
Support the creation of stakeholder analytics and Key Performance Indicators (KPIs) to the business that help improve forecasting, contracting, pricing decisions, timing and general business planning.
Gain a deep understanding of site capabilities, operational gaps and develop gap resolution plans in partnership with HCPs and sites of care.
Engage with institutional leadership, administration, revenue cycle management, finance, managed care, contracting, pharmacy, prior authorization departments, and care teams.
Support HCP champion through formulary inclusion/decision process and monitor Pharmacy and Therapeutic Committee timelines to confirm site readiness.
Responsible for eliminating and/or significantly reducing barriers to patient access and reimbursement across all payer segments.
Support high‑touch patient and caregiver support programs, including site of care referral management, travel logistics and patient affordability.
Support development of training material, SOPs, and work instructions to educate around Capricor channel and patient support offerings.
Onboard sites of care to be operationally confident in Capricor’s buy‑and‑bill and specialty pharmacy procurement process, reimbursement support services and tools, prior authorization/reauthorization patient enrollment process best practices, and navigation of the denial/appeal process.
Work collaboratively with Sales leadership to identify access challenges and solutions.
Responsible for understanding and upholding Capricor’s Legal and Compliance guidance at a customer and field leadership level related to access, cost and reimbursement issues.
Attend regional sales meetings to represent the Patient Access & Reimbursement team.
Provide updates to Senior Leadership on health of the launch, key access concerns, and collaborative solutions in place to address known access issues.
Support distribution provider and vendor quarterly and annual business reviews, and analytic insights to support company quarterly and annual reporting.
Monitor competition to understand how the evolving market will impact current and future market and patient access strategies.
Identify and develop Provider Access and Patient Advocacy Groups, Physician Key Advocate Leaders (KALs) and societal advocates to support disease/product awareness and patient access to Capricor’s product portfolio.
Provide subject‑matter expertise to the broader organization, including HCP access and reimbursement, distribution, and payer coverage access intelligence.
Work with the Capricor Commercial Ops/analytics team and Sales to map and report on updates in HCP/Patient access, patient referral, SPP distribution, trend monitoring, and patient out‑of‑pocket information.
Represent Capricor at key industry conferences (e.g., Assemblia, Physician Society, Patient Advocacy, etc.).
Ensure that all activities and interactions are carried out with the highest ethical and professional standards, and that all work is accomplished with quality and in accordance with Capricor values.

Additional Responsibilities

Recruits, interviews, hires, and trains new staff.
Provides constructive and timely performance feedback and evaluations.
Vendor management and negotiation skills.
Works to improve tools and processes within functional area.
Ability to work in a fast‑paced, rapidly scaling environment.
Exceptional attention to detail and documentation discipline.
Ability to influence without authority across cross‑functional teams.
Problem‑solving and decision‑making ability.
Develop and manage a functional budget and ensure efficient allocation of resources to achieve strategic patient support objectives.

Location & Travel

This position is field‑based (remote) but is expected to be in the San Diego, CA office approximately 2–3 times per quarter, or other frequency as required by business necessity or as reasonably required by the position’s manager. Domestic travel will be required up to 50%, based upon business needs.

Minimum Qualifications

Minimum bachelor’s degree (science or business preferred; MBA or advanced degree a plus).
Minimum 10+ years of overall industry experience in BioPharma, Healthcare services (hospital patient case‑management, patient support, provider reimbursement, market access, sales, sales management, or training).
Minimum 5 years of progressive patient‑support, payer (government and commercial) and PBM, and specialty pharmacy engagement, and patient case‑management responsibility.
Strong leadership experience; has led high‑functioning, self‑directed teams.
Experience with rare/orphan drugs is required. Therapeutic area and pediatric infused drug experience is a plus.
Product launch experience is required, and company start‑up experience preferred.
Demonstrated expertise in reimbursement, coding, claims adjudication, prior authorization processes, appeals management, and provider education.
Deep understanding of specialty pharmacy, buy‑and‑bill distribution models, payer policies, government and commercial reimbursement, and the evolving healthcare access landscape.
Strong knowledge of provider economics, hospital finance, revenue cycle management, and infusion site operations.
Knowledge and understanding of compliance with HIPAA and OIG guidance in the rare disease space.
Hospital finance, claims processing, and/or billing/coding experience preferred.
Excellent working knowledge of patient support programs, including reimbursement support, financial assistance adherence programs.
Strong understanding of the PA process, denial management, product acquisition via the specialty pharmacy, buy‑and‑bill, J‑code, and reimbursement within multiple sites of care.
Understands both the buy‑and‑bill process and specialty pharmacy networks, managed care, benefit design, government payers and their impact on product access with excellent working knowledge of evolving market access and reimbursement landscape.
Demonstrated flexibility to adapt to a changing environment, implement creative solutions to complex problems, and ability to function in a project leadership role.
Ability to develop and maintain strong internal and external relationships, including direct collaboration with vendors and other third parties.
Superior interpersonal, communication, analytical and presentation skills, with great attention to detail.
Advance Virtual / Zoom, Microsoft Excel, Word and PowerPoint skills.
Passionate about patients and building a new commercial organization.