Senior Director, Head of Patient Services

Job description

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is **Deramiocel**(*CAP-1002*), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. The Senior Director, Head of Patient Services will lead the design, implementation, and ongoing management of Capricor's U.S. patient services organization in support of the anticipated launch of deramiocel, Capricor's lead cell therapy for Duchenne muscular dystrophy. This leader will establish a high-touch, compliant, and scalable support model that helps patients, caregivers, healthcare providers, and treatment centers navigate access, affordability, and treatment initiation. This is a hands-on launch leadership role with end-to-end accountability for patient services strategy, hub operations, affordability programs, site-of-care coordination, vendor performance, data and reporting, and team development. The position will partner closely with Market Access, Trade and Distribution, Commercial Operations, Finance, Medical, Quality, IT, Legal, and Compliance, as well as external hub, specialty pharmacy, distribution, and treatment-center partners. ### Responsibilities **Patient Services Strategy and Operating Model** - Develop and execute the U.S. patient services strategy and launch-readiness plan, with clear milestones, decision points, risks, and accountabilities. - Build and lead an integrated patient support model spanning referral and enrollment, benefits investigation, prior authorization and appeal support, case management, affordability, treatment coordination, and ongoing patient support. - Map, standardize, and continuously improve the patient and caregiver journey to reduce access friction and support timely, coordinated treatment initiation. - Establish governance, escalation pathways, business continuity plans, and service standards across internal teams and external partners. **Hub, Access, and Affordability Operations** - Lead the implementation and day-to-day oversight of hub and other patient services vendors, including workflow design, staffing assumptions, training, quality controls, and operational escalation. - Design and manage financial assistance and affordability programs, subject to applicable legal and compliance requirements. - Partner with Market Access and field reimbursement colleagues to align patient services workflows with payer policies, reimbursement requirements, and access pathways. **Site-of-Care and Treatment Coordination** - Lead patient services support for treatment-center onboarding and readiness, in coordination with Medical, Commercial, and operational partners. - Define clear handoffs among the hub, treatment centers, specialty pharmacy and distribution partners, field teams, patients, and caregivers. - Develop escalation protocols for access barriers, incomplete referrals, scheduling delays, treatment-center capacity constraints, and other launch-critical issues. - Support a consistent, high-touch experience for patients and caregivers before, during, and after treatment initiation, within the approved program scope. **Data and Performance Management** - Lead vendor implementation, budget management, and ongoing business reviews in partnership with Procurement, Finance, Legal, Compliance, and IT. - Establish service-level agreements, key performance indicators, quality measures, and launch-readiness dashboards that provide timely visibility into patient access, operational performance, patient experience, and emerging risks. - Partner with Commercial Operations and IT to define data requirements, integrations, reporting cadence, privacy controls, and issue-resolution processes across the vendor ecosystem. - Use operational insights to identify root causes, drive corrective actions, and continuously improve program effectiveness and scalability. **Compliance, Quality, and Operational Excellence** - Develop and maintain SOPs, work instructions, training materials, and documentation standards for patient- and provider-facing activities. - Ensure patient services programs operate in alignment with applicable regulatory, legal, privacy, quality, and compliance requirements and Capricor policies. - Partner with Quality and Compliance on monitoring, auditing, deviation management, corrective actions, and vendor oversight, as appropriate. - Maintain inspection-ready documentation and promote a culture of patient focus, accountability, and disciplined execution. **Team Leadership** - Build and lead the patient services organization, including future roles supporting treatment-center onboarding, nurse education, patient engagement, and reimbursement coordination, as business needs evolve. - Own workforce planning, role design, hiring, onboarding, training, coaching, and performance management to support launch readiness and post-launch scale. - Set clear objectives and operating norms, develop team capabilities, and foster effective collaboration across internal and external stakeholders. - Serve as the senior internal subject-matter expert for patient services and provide concise updates, recommendations, and risk assessments to executive leadership. - Perform other duties as assigned consistent with the scope and seniority of the role. ### Requirements - Bachelor's degree required. - Progressive experience in patient services, hub operations or a related function within the biotechnology or pharmaceutical industry, including meaningful leadership responsibility. - Demonstrated success building, launching, or scaling patient support programs for rare disease, specialty, or other complex therapies. - Deep working knowledge of benefits investigation, prior authorization and appeals processes, case management, affordability programs, and the operational realities of patient access. - Experience managing external vendors, budgets, contracts, implementation plans, service levels, and performance improvement. - Strong cross-functional leadership, problem-solving and decision-making skills, with the ability to translate strategy into detailed execution. - Ability to operate effectively in a fast-paced, growth-stage environment with evolving priorities and a high degree of accountability. - Excellent written, verbal, and executive communication skills, with strong attention to detail and documentation discipline. ### Preferred Qualifications - Advanced degree or clinical credential, such as an MBA, MPH, RN, PharmD, or comparable qualification. - Experience with cell therapy, gene therapy, infused products, or other therapies requiring coordinated treatment-center readiness and high-touch patient support. - Experience establishing patient services capabilities from the ground up in a pre-commercial or early-commercial biotechnology company. - Familiarity with rare-disease patient communities, caregiver needs, and family-centered support models. - Experience with patient services technology, data integrations, dashboards, privacy requirements, and operational analytics. ### Core Competencies - Strong problem-solving and decision-making skills. - Vendor management and negotiation skills. - Ability to work in a fast-paced, rapidly scaling environment. - Exceptional attention to detail and documentation discipline. - Ability to influence without authority and collaborate effectively across functions.