Capricor Therapeutics, Inc.
Senior Director of Pharmacovigilance
Capricor Therapeutics, Inc., San Diego, California, United States, 92189
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 looking for a Senior Director of Pharmacovigilance with deep expertise within biotechnology, ideally in rare diseases or cell therapies. This role will play a pivotal part in building the pharmacovigilance function as we advance our lead programs following recent clinical milestones. This individual will ensure high-quality, compliant safety processes, oversee vendors and safety surveillance, and facilitate rapid communication of safety concerns. This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel.
Responsibilities
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.
Requirements
Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred).
Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role.
Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets.
Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements).
Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system.
Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders.
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, resource-constrained environment.
Willingness to travel up to 20-30% for inspections, meetings, and collaborations.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).
Equivalent combination of education and experience may be considered.
Preferred Qualifications
Experience with cellular or gene therapy products, or other complex biologics/rare diseases.
Ability to transition between strategic planning and hands-on operational execution in a small biotech environment.
Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance.
Work Environment & Physical Demands
Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions.
Ability to sit for extended periods during virtual or in-person meetings and computer work.
Occasional travel requiring mobility, such as walking through conference venues or site visits.
$250,000 - $325,000 a year
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
#J-18808-Ljbffr
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 looking for a Senior Director of Pharmacovigilance with deep expertise within biotechnology, ideally in rare diseases or cell therapies. This role will play a pivotal part in building the pharmacovigilance function as we advance our lead programs following recent clinical milestones. This individual will ensure high-quality, compliant safety processes, oversee vendors and safety surveillance, and facilitate rapid communication of safety concerns. This new headcount position supports our major milestone of positive Phase 3 results and continued advancement of deramiocel.
Responsibilities
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.
Requirements
Bachelor's degree in a health science field (MD, PharmD, PhD, or equivalent preferred).
Minimum of 8+ years of progressive experience in Pharmacovigilance/Drug Safety within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or management role.
Mandatory prior experience successfully preparing for and executing the launch of a novel therapeutic product, preferably in the US and EU markets.
Deep understanding of global PV regulations, guidelines, and ICH standards (e.g., FDA, EMA, MHRA, and other major health authority requirements).
Proven experience in establishing or significantly contributing to the implementation of a validated safety database and PV quality management system.
Exceptional written and verbal communication skills, capable of presenting complex safety data to regulatory authorities and internal stakeholders.
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, resource-constrained environment.
Willingness to travel up to 20-30% for inspections, meetings, and collaborations.
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).
Equivalent combination of education and experience may be considered.
Preferred Qualifications
Experience with cellular or gene therapy products, or other complex biologics/rare diseases.
Ability to transition between strategic planning and hands-on operational execution in a small biotech environment.
Demonstrated ability to lead complex safety issues and make sound, timely decisions regarding patient safety and regulatory compliance.
Work Environment & Physical Demands
Professional office environment (San Diego, CA) or remote work setup with standard business hours, subject to flexibility for global interactions.
Ability to sit for extended periods during virtual or in-person meetings and computer work.
Occasional travel requiring mobility, such as walking through conference venues or site visits.
$250,000 - $325,000 a year
Why Capricor? Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.
Come Work With Us! At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.
#J-18808-Ljbffr