Senior Director, Medical Affairs (MD Required)

United States·San DiegoRemoteFull-time (exempt)senior

OtherDirectorHealthcare

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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.

Capricor is seeking Senior Director of Medical Affairs with deep expertise in biotechnology, ideally in rare diseases or cell therapies. This position will play a pivotal role in building the medical affairs function as we advance our lead programs following recent clinical milestones. This individual will define the roadmap for our scientific narrative, drive clinical scientific messaging, foster key relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and patient advocacy groups in the DMD and BMD communities, and ensure high-integrity, compliant processes for stakeholder engagement. This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel. They will lead cross-functional efforts to bridge clinical development with commercialization readiness, fostering deep relationships and evidence generation strategies necessary to drive program success and ongoing medical excellence.

Develop and execute medical affairs strategies aligned with company goals, including evidence generation, scientific exchange, and medical input into cross-functional teams.

Build and maintain strong relationships with HCPs, KOLs, and patient advocacy organizations in DMD, Becker muscular dystrophy (BMD), and related fields through local, national, and international meetings, 1:1 site visits, and advisory boards.

Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement, ensuring adherence to regulatory guidelines (e.g., FDA, ICH).

Create and refine the clinical scientific and value story for deramiocel through internal consultations, external expert input, and data analysis to support program progression.

Lead scientific communications, including publications, congress presentations, and medical information responses, while overseeing vendors as needed.

Provide medical expertise to support commercialization readiness activities, including training, payer interactions, and real-world evidence initiatives.

Work cross-functionally with clinical development, regulatory affairs, commercial, and quality teams to drive business impact and team success.

Identify opportunities for continuous improvement in medical affairs operations, fostering a culture of innovation and compliance.

Monitor emerging scientific data, competitive landscape, and therapeutic trends in neurology, myology, cardiology, and rare diseases to inform strategy.

Perform such other duties as may be assigned from time to time.

MD required, with experience in neurology, myology, cardiology, or a closely related field, and demonstrated clinical scientific competence.

Deep experience and commitment to excellence in medical affairs, with a proven track record in biotechnology or pharmaceuticals.

Experience working in a small company environment, thriving in dynamic, resource-constrained settings.

Passionate "can-do" mentality with evidence of high emotional intelligence (EQ) and collaborative teamwork.

Exceptional communication, presentation, and interpersonal skills to engage stakeholders at all levels.

Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines.

Ability to work independently, multi-task, and meet aggressive deadlines in a fast-paced environment.

Willingness to travel up to 30-40% for meetings, site visits, and conferences.

Previous experience with DMD, BMD, or other muscle or cardiomyopathic indications.

Experience with pre-launch or commercialization activities in a Medical Affairs capacity.

Experience with complex cell or gene therapy (ATMP) products.