Atlas Venture
Senior Director, Drug Safety & Pharmacovigilance Operations
Atlas Venture, Watertown, Massachusetts, us, 02472
Senior Director, Drug Safety & Pharmacovigilance Operations
Company Address:
200 Arsenal Yards Blvd, Suite 230, Watertown, MA 02472, US
About Kymera Therapeutics Kymera is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics that selectively degrade disease‑causing proteins by harnessing the body’s own natural protein degradation system.
Job Description 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.
The company is focused on building an industry‑leading pipeline of oral small‑molecule degraders for patients with these conditions.
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 and 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 functions, ensuring robust safety surveillance, compliance, and operational excellence 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).
Oversee PV vendor(s) performance and compliance via monitoring Key Performance Indicators (KPIs), periodic governance meetings, and implementation of corrective and preventative action plans.
Partner cross‑functionally with Clinical Development, Regulatory Affairs, Quality, and Medical Affairs to integrate safety operational strategies 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.
Collaborate with Data Management and PV vendors on the reconciliation of adverse events between the clinical and safety databases, issuing queries and developing safety reconciliation plans.
Provide operational oversight for the preparation and submission of aggregate safety reports (e.g., DSUR), safety data collection, literature reviews, regulatory responses, and clinical trial application submissions.
Oversee review and archival of PV‑related records in 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 (Master’s/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 with PV processes for vendor oversight, individual case handling, signal management, aggregate data review, aggregate reporting, 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 who can translate complex safety data into actionable insights for regulatory and clinical decision‑making.
Kymera Therapeutics is proud to be an equal‑opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
#J-18808-Ljbffr
Company Address:
200 Arsenal Yards Blvd, Suite 230, Watertown, MA 02472, US
About Kymera Therapeutics Kymera is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics that selectively degrade disease‑causing proteins by harnessing the body’s own natural protein degradation system.
Job Description 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.
The company is focused on building an industry‑leading pipeline of oral small‑molecule degraders for patients with these conditions.
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 and 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 functions, ensuring robust safety surveillance, compliance, and operational excellence 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).
Oversee PV vendor(s) performance and compliance via monitoring Key Performance Indicators (KPIs), periodic governance meetings, and implementation of corrective and preventative action plans.
Partner cross‑functionally with Clinical Development, Regulatory Affairs, Quality, and Medical Affairs to integrate safety operational strategies 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.
Collaborate with Data Management and PV vendors on the reconciliation of adverse events between the clinical and safety databases, issuing queries and developing safety reconciliation plans.
Provide operational oversight for the preparation and submission of aggregate safety reports (e.g., DSUR), safety data collection, literature reviews, regulatory responses, and clinical trial application submissions.
Oversee review and archival of PV‑related records in 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 (Master’s/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 with PV processes for vendor oversight, individual case handling, signal management, aggregate data review, aggregate reporting, 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 who can translate complex safety data into actionable insights for regulatory and clinical decision‑making.
Kymera Therapeutics is proud to be an equal‑opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
#J-18808-Ljbffr