Senior Director, Medical Affairs jobs in United States
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Capricor Therapeutics, Inc. · 3 weeks ago

Senior Director, Medical Affairs

Capricor Therapeutics is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. They are seeking a Senior Director of Medical Affairs who will play a pivotal role in building the medical affairs function and driving clinical scientific messaging while fostering relationships with healthcare professionals and patient advocacy groups.

BiotechnologyHealth CareMedicalTherapeutics

Responsibilities

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

Qualification

PhDMDMedical Affairs expertiseRegulatory compliance knowledgeExperience in biotechnologyDMD/BMDCellGene therapy experienceMicrosoft Office proficiencyCommunication skillsTeamworkEmotional intelligencePresentation skills

Required

PhD or MD (preferably in neurology, myology, cardiology, or a related field) with 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
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
10+ years of relevant experience in medical affairs preferred, or an equivalent combination of education and experience

Preferred

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

Company

Capricor Therapeutics, Inc.

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Capricor Therapeutics is a publicly traded (NASDAQ: CAPR) biotechnology company with a mission to develop groundbreaking therapies that make a meaningful impact on patients’ lives.

Funding

Current Stage
Public Company
Total Funding
$329.5M
Key Investors
Nippon ShinyakuNational Institutes of HealthCalifornia Institute for Regenerative Medicine
2025-12-05Post Ipo Equity· $150M
2024-10-17Post Ipo Equity· $75M
2024-09-17Post Ipo Equity· $15M

Leadership Team

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AJ Bergmann
Chief Financial Officer
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Company data provided by crunchbase