SERM Senior Scientific Director, Oncology
GSK
July 01, 2026
Remote friendly (Waltham, MA)
United States
Medical Affairs
Position Summary
Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets. Accountable for driving safety strategy, benefit-risk assessment, and proactive identification, evaluation, and management of safety risks across clinical development and post-marketing.
Key Responsibilities
- Define and drive clinical safety and pharmacovigilance strategy for assigned oncology assets aligned with global business objectives.
- Lead safety governance: escalation, communication, and resolution of emerging safety issues.
- Anticipate, identify, and address safety signals; ensure timely implementation of risk mitigation.
- Provide strategic recommendations on benefit-risk profiles for development and lifecycle decisions.
- Exercise expert scientific judgment in evaluation and interpretation of complex safety data.
- Lead safety data analyses and signal detection with robust conclusions and documentation.
- Guide causality assessments, benefit-risk evaluations, and safety evidence generation.
- Oversee proactive identification and assessment of safety signals from trials, post-marketing data, and real-world evidence.
- Develop and implement risk management strategies (labeling updates, risk minimization, stakeholder communication).
- Lead and influence global, matrixed teams; collaborate across clinical, regulatory, medical, and commercial functions.
- Provide strategic oversight of regulatory safety documents and Health Authority responses; ensure compliance with global pharmacovigilance regulations (ICH, GVP, CIOMS).
Basic Qualifications
- Advanced degree (PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent).
- 7+ years in pharmacovigilance/drug safety (pharma/biotech).
- Deep expertise in clinical safety (development and post-marketing).
- Demonstrated signal detection and evaluation; benefit-risk assessment and safety decision-making; risk management strategy development.
- Knowledge of ICH/GVP/CIOMS; experience in complex global matrix organizations; ability to influence decisions and lead safety strategy at program/portfolio level.
Preferred Qualifications
- Leadership in global SERM/safety; US and other regions regulatory interactions/inspections.
- Pharmacoepidemiology/real-world evidence/biostatistics; experience preparing DCSI, PBRERs, or DSURs.
- Oncology TA expertise; experience leading global safety teams/programs.
- Interaction with Health Authorities and regulatory submissions; influence senior leadership/governance; mentor/develop scientific talent.
Application Instructions
- If the role aligns with your skills, submit your application.
Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets. Accountable for driving safety strategy, benefit-risk assessment, and proactive identification, evaluation, and management of safety risks across clinical development and post-marketing.
Key Responsibilities
- Define and drive clinical safety and pharmacovigilance strategy for assigned oncology assets aligned with global business objectives.
- Lead safety governance: escalation, communication, and resolution of emerging safety issues.
- Anticipate, identify, and address safety signals; ensure timely implementation of risk mitigation.
- Provide strategic recommendations on benefit-risk profiles for development and lifecycle decisions.
- Exercise expert scientific judgment in evaluation and interpretation of complex safety data.
- Lead safety data analyses and signal detection with robust conclusions and documentation.
- Guide causality assessments, benefit-risk evaluations, and safety evidence generation.
- Oversee proactive identification and assessment of safety signals from trials, post-marketing data, and real-world evidence.
- Develop and implement risk management strategies (labeling updates, risk minimization, stakeholder communication).
- Lead and influence global, matrixed teams; collaborate across clinical, regulatory, medical, and commercial functions.
- Provide strategic oversight of regulatory safety documents and Health Authority responses; ensure compliance with global pharmacovigilance regulations (ICH, GVP, CIOMS).
Basic Qualifications
- Advanced degree (PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent).
- 7+ years in pharmacovigilance/drug safety (pharma/biotech).
- Deep expertise in clinical safety (development and post-marketing).
- Demonstrated signal detection and evaluation; benefit-risk assessment and safety decision-making; risk management strategy development.
- Knowledge of ICH/GVP/CIOMS; experience in complex global matrix organizations; ability to influence decisions and lead safety strategy at program/portfolio level.
Preferred Qualifications
- Leadership in global SERM/safety; US and other regions regulatory interactions/inspections.
- Pharmacoepidemiology/real-world evidence/biostatistics; experience preparing DCSI, PBRERs, or DSURs.
- Oncology TA expertise; experience leading global safety teams/programs.
- Interaction with Health Authorities and regulatory submissions; influence senior leadership/governance; mentor/develop scientific talent.
Application Instructions
- If the role aligns with your skills, submit your application.