Capricor Therapeutics, Inc.

Director

• Lead and coordinate statistical related activities to support clinical studies including but not limited to supporting the design, execution, analysis, interpretation, and reporting of clinical trials as well as communication of data evidence.
• Support is the statistical aspects of business-critical and/or regulatory commitments, provides input to program plans, and represent the Biostatistics function for cross-functional and intra-departmental teams or working groups.
• Functions as the lead statistician for assigned clinical projects.
• Performs management of in-house and/or outsourced biostatistical activities.
• May engage with regulatory authorities on compound/indication level discussions.
• Prepare or review the clinical study protocols, case report forms, statistical analysis plans, and table shells as needed.
• Create programs for data management activities, compliant analysis datasets, and statistical analysis of the clinical trial data.
• Prepare the statistical section of clinical trial reports and presentations of the results to the team.
• Demonstrate solid understanding of regulatory guidance and statistical methodology as applied to clinical studies in pharmaceutical development.
• Presenting interim trial data to Data Monitoring Committees (DMCs).
• Writing statistical reports and memos with minimal guidance.
• Programming complex datasets.
• Leading or supporting complex analyses, including efficacy and futility interim analyses for DMCs.
• Supports the preparation and documentation of statistical analyses to enable management to write and support trial reports and publications.
• Helps ensure that new and revised statistical standards, tests, and processes are implemented for increased accuracy and efficiency.
• Reviewing statements of work, proposals, and budgets.
• Managing multiple projects and a majority of own workload.
• Perform such other duties as may be assigned from time to time.

Director of Biostatistics

QA Engineer

• Support GCP compliance for clinical operations to ensure regulatory adherence.
• Assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity.

Clinical Quality Assurance – GCP Specialist

• Review, investigate, and manage deviations, non-conformances, and CAPA activities across the organization.
• Conduct root cause analyses (RCA) and risk assessments for reported quality issues.
• Collaborate with cross-functional teams (Manufacturing, MSAT, QC, Clinical, and R&D) to ensure timely resolution of quality events.
• Track and maintain documentation of deviations and CAPAs in compliance with cGMP, FDA, and other applicable regulatory guidelines.
• Monitor trends in deviations and CAPAs to identify systemic issues and recommend preventative measures.
• Assist in preparing and supporting internal and external audits and inspections.
• Develop, update, and maintain SOPs and quality documentation, including but not limited to those related to deviations and CAPA processes.
• Provide training to staff on deviations, deviation reporting, and CAPA procedures.
• Support continuous improvement initiatives by identifying opportunities to enhance quality processes.
• Host/Lead Deviation Review Board (DRB) meetings.
• Triage with cross-functional teams to ensure issues are resolved in a timely, quality manner.

Quality Assurance Associate II – Quality Events Team

• 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.

Director of Biostatistics

Clinical Quality Assurance – GCP Specialist

Quality Assurance Associate II – Quality Events Team

Senior Director – Pharmacovigilance

Senior Director, Medical Affairs