Kymera Therapeutics · 1 day ago
Senior Director, Drug Safety & Pharmacovigilance Operations
Greater Boston
Full-time
Hybrid
Director/Executive
$235K/yr - $330K/yr
12+ years expKymera Therapeutics is a clinical-stage biotechnology company focused on pioneering targeted protein degradation to develop innovative medicines. The Senior Director of Drug Safety & Pharmacovigilance Operations will lead global pharmacovigilance and safety efforts, ensuring compliance and operational excellence while overseeing safety data collection and reporting from clinical trials.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting
Lead and mentor a growing PV team, fostering a culture of scientific rigor, compliance, and collaboration
Serve as the operational owner for global safety systems, ensuring accurate, timely data capture and reporting in accordance with ICH, FDA, EMA, MHRA, and other regulatory requirements
Oversee vendor selection and management for PV activities (e.g., safety database hosting, ICSR processing & review, regulatory submissions)
Oversees PV vendor(s) performance and compliance via monitoring Key Performance Indicators (KPIs) and metrics, periodic governance meetings, and implementation of effective Corrective and Preventative Action plans
Partner cross-functionally with Clinical Development, Regulatory Affairs, Quality, and Medical Affairs to ensure safety operational strategies are integrated across all development programs
Collaborate with medical safety and cross functionally to facilitate signal and risk management activities, including internal safety committee meetings
Lead inspection readiness and interactions with global health authorities for safety-related audits or inquiries
Develop and implement standard operating procedures (SOPs), safety management plans (SMPs), and safety agreements with partners and CROs
Collaborates with Data Management and the PV vendor in the reconciliation of adverse events between the clinical and safety databases and issue queries. Develop safety reconciliation plans
Provide operational oversight for preparation and submission of aggregate safety reports (e.g. DSUR), safety data collection, literature reviews, regulatory responses, and clinical trial application submissions
Oversees review and archive of PV-related records in various documentation management systems (e.g. TMF, PSMF)
Contribute to long-term organizational strategy and capability building within Drug Safety and Pharmacovigilance
Qualification
Required
Health care professional degree (e.g. RN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science discipline is preferred
Minimum 12–15 years of pharmacovigilance experience within the biopharmaceutical industry, including at least 5 years in a senior leadership role
Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes
Experience in PV processes for vendor oversight, individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections
Proven track record managing vendors and building internal PV capabilities in a fast-paced, innovative environment
Exceptional communication and cross-functional collaboration skills
Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making
Benefits
Eligibility for annual bonus
Equity participation
Comprehensive benefits
Company
Kymera Therapeutics
Kymera Therapeutics is a biotechnology company that specializes in the field of targeted protein degradation.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.96BKey Investors
Biotechnology Value FundBiotechnology Value Fund,Redmile Group6 Dimensions Capital,Bessemer Venture Partners,Pfizer Venture Investments
2025-12-10Post Ipo Equity· $602M
2025-06-26Post Ipo Equity· $250.8M
2024-08-19Post Ipo Equity· $225M
Leadership Team
Nello Mainolfi
Founder, President and Chief Executive Officer
Jeremy Chadwick
Chief Operating Officer
Recent News
2026-01-16
Company data provided by crunchbase