Capricor Therapeutics, Inc.

Director

• Design, implement, and manage a robust, compliant, and scalable global pharmacovigilance system, including policies, procedures, and infrastructure suitable for cellular therapy products.
• Develop and lead pharmacovigilance activities essential for program progression, including creation of the Risk Management Plan (RMP), Pharmacovigilance System Master File (PSMF), and required safety labeling sections.
• Select, onboard, and oversee pharmacovigilance operations vendors and safety database providers to ensure high-quality case management, reporting, and regulatory compliance.
• Direct and execute global safety surveillance activities, including monitoring, evaluation, and interpretation of safety data from various sources such as spontaneous reports, literature, and post-approval studies.
• Lead signal detection and management processes, ensuring periodic review and updates to the RMP and PSMF.
• Oversee and review aggregate safety reports (e.g., PSURs/PBRERs, DSURs) for submission to global health authorities.
• Serve as the pharmacovigilance lead during health authority inspections (e.g., FDA, EMA) and internal audits.
• Collaborate closely with Regulatory Affairs on submissions and labeling, with Clinical Operations/Development for seamless safety transitions, and with Commercial and Medical Affairs teams to provide expertise and training on safety reporting.
• Chair and lead the internal Safety Review Team (SRT) for ongoing evaluation of product benefit-risk profiles.
• Interface with vendors such as PPD and Syneos, clinical trial teams, CMO, and commercial partners to prepare safety documentation and oversee post-marketing clinical safety surveillance.
• Work cross-functionally to drive business impact, team success, and continuous improvement in pharmacovigilance operations.
• Monitor emerging safety data, regulatory trends, and therapeutic advancements in rare diseases and biologics to inform strategy.
• Perform such other duties as may be assigned from time to time.

Senior Director – Pharmacovigilance

• 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.

Senior Director – Pharmacovigilance

Senior Director, Medical Affairs