Senior Director, Drug Safety & Pharmacovigilance Operations

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. 

 

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

 

How you’ll make an impact:

The Senior Director of Drug Safety & Pharmacovigilance Operations will lead Kymera’s global pharmacovigilance (PV) and safety  , ensuring robust safety surveillance, compliance, and operational excellence and compliance across all programs. This leader will oversee the collection, evaluation, and reporting of safety data from clinical trials, shaping the company’s safety governance framework and supporting strategic decisions across development and regulatory interactions.

• 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.

 

Skills and experience you’ll bring:

• 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, indivi