The SERM Scientific Director provides medical and scientific leadership in the evaluation and management of product safety across clinical development and post‑marketing phases. This role is responsible for assessing benefit‑risk profiles, identifying and managing safety concerns, and supporting regulatory and governance activities to ensure patient safety. The position operates within a global, cross‑functional environment and may include leadership or mentoring responsibilities within a matrix structure.
Responsibilities
* Lead pharmacovigilance and risk management strategy across clinical development and post‑marketing products.
* Evaluate and interpret safety data to inform benefit‑risk assessments and support decision‑making.
* Identify, assess, and elevate safety signals, ensuring appropriate mitigation strategies are implemented.
* Contribute to safety components of regulatory submissions and interactions with regulatory authorities.
* Represent safety in cross‑functional project teams and governance forums.
* Support inspection readiness activities and contribute to continuous process improvement initiatives.
* Collaborate effectively with internal and external stakeholders to communicate safety information.
* Provide leadership, mentoring, or coaching within a matrix environment, where applicable.
Qualifications
* Bachelor's Degree in a health sciences or healthcare‑related discipline (e.g., life sciences, pharmacy, nursing, or medicine).
* Demonstrated experience in pharmacovigilance, drug safety, or a closely related field.
* Experience in safety evaluation and risk management within clinical development and/or post‑marketing settings.
* Knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP).
* Experience working within cross‑functional or matrix team environments.
* Ability to analyse complex data and communicate findings clearly to diverse stakeholders.
Preferred Qualifications (Desirable)
* Advanced degree (e.g., MSc, PhD, PharmD, MD, or equivalent).
* SERM Oncology experience.
* Experience leading or influencing cross‑functional teams or projects.
* Experience contributing to regulatory submissions or interactions with health authorities.
* Experience supporting audits or inspections in a regulated environment.
* Experience within a global pharmaceutical or biotechnology organisation.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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