SERM Scientific Director
GSK
July 02, 2026
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Position Summary
Provides advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally.
Key Responsibilities
- Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials.
- Drive evaluation and interpretation of safety data, including signal detection and assessment.
- Develop strategic approaches for safety issue evaluation within clinical development programs.
- Contribute safety components of global regulatory submissions (e.g., INDs, DSURs, IBs).
- Perform literature review, clinical data synthesis, and integrated safety analyses.
- Ensure high-quality, timely delivery of outputs while managing multiple priorities.
Cross-Functional Matrix Leadership
- Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams.
- Lead cross-functional efforts to address urgent and complex product safety issues.
- Partner with Safety Physicians and stakeholders to prepare and present at Safety Review Team (SRT) meetings.
- Escalate emerging safety issues to senior leadership and governance bodies.
- Build relationships and effectively lead in a global matrix environment; mentor junior team members as applicable.
Communication, Influence, and Strategy
- Present safety recommendations and emerging risks to senior governance committees.
- Represent GSK with regulatory authorities, external experts, and partners.
- Apply strategic thinking; contribute to long-term safety and clinical development strategies.
Basic Qualifications
- Degree in health or life sciences (BS, PharmD, MD, PhD, or equivalent).
- Minimum 5 years in pharmacovigilance/drug safety/safety evaluation.
- Practical experience with signal detection, safety surveillance, and risk management across clinical development and post-marketing.
- Knowledge of global pharmacovigilance requirements and drug development processes.
- Strong clinical/scientific judgement interpreting clinical and safety data.
Preferred Qualifications
- Advanced degree (PharmD, PhD, MD) or equivalent; 10+ years pharmacovigilance/medical safety.
- Experience preparing regulatory safety documents and interacting with regulators.
- Experience leading safety activities in a relevant therapeutic area.
- Ability to lead/influence cross-functional matrix teams; experience supporting inspections/audits/readiness.
How to apply
Submit your CV and a brief cover note outlining relevant experience and interest.
Provides advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally.
Key Responsibilities
- Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials.
- Drive evaluation and interpretation of safety data, including signal detection and assessment.
- Develop strategic approaches for safety issue evaluation within clinical development programs.
- Contribute safety components of global regulatory submissions (e.g., INDs, DSURs, IBs).
- Perform literature review, clinical data synthesis, and integrated safety analyses.
- Ensure high-quality, timely delivery of outputs while managing multiple priorities.
Cross-Functional Matrix Leadership
- Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams.
- Lead cross-functional efforts to address urgent and complex product safety issues.
- Partner with Safety Physicians and stakeholders to prepare and present at Safety Review Team (SRT) meetings.
- Escalate emerging safety issues to senior leadership and governance bodies.
- Build relationships and effectively lead in a global matrix environment; mentor junior team members as applicable.
Communication, Influence, and Strategy
- Present safety recommendations and emerging risks to senior governance committees.
- Represent GSK with regulatory authorities, external experts, and partners.
- Apply strategic thinking; contribute to long-term safety and clinical development strategies.
Basic Qualifications
- Degree in health or life sciences (BS, PharmD, MD, PhD, or equivalent).
- Minimum 5 years in pharmacovigilance/drug safety/safety evaluation.
- Practical experience with signal detection, safety surveillance, and risk management across clinical development and post-marketing.
- Knowledge of global pharmacovigilance requirements and drug development processes.
- Strong clinical/scientific judgement interpreting clinical and safety data.
Preferred Qualifications
- Advanced degree (PharmD, PhD, MD) or equivalent; 10+ years pharmacovigilance/medical safety.
- Experience preparing regulatory safety documents and interacting with regulators.
- Experience leading safety activities in a relevant therapeutic area.
- Ability to lead/influence cross-functional matrix teams; experience supporting inspections/audits/readiness.
How to apply
Submit your CV and a brief cover note outlining relevant experience and interest.