Business Introduction
At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, using our understanding of the immune system combined with cutting‑edge technology to transform lives.
Position Summary
As SERM Senior Medical Director, Oncology, you will lead clinical safety and pharmacovigilance strategy for oncology assets within Global Safety. You will oversee rigorous review, interpretation and communication of safety data, ensuring timely identification, escalation and management of safety issues. Working in a global, cross‑functional matrix, you will collaborate with senior governance and partner teams to drive evidence‑based safety decisions. You will also mentor SERM colleagues, strengthening safety and risk‑management capabilities.
Responsibilities
* Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit‑risk assessment and proactive risk‑management strategies.
* Oversee the review, interpretation and communication of safety data; identify, elevate and manage safety issues through established safety governance forums.
* Develop and implement safety strategies, policies and processes aligned with Global Safety operational and strategic plans.
* Coach and mentor medical and scientific colleagues in SERM in signal evaluation, risk management and preparation of regulatory safety deliverables.
* Lead in a global, cross‑functional matrix, building strong collaborative relationships and influencing internal and external stakeholders on safety topics.
* Lead or oversee SERM safety input into due diligence and other key strategic activities, ensuring safety perspectives shape decision‑making.
Basic Qualification
* Medical degree, with completion of a formal postgraduate clinical training, residency or specialty training.
* Experience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety.
* Experience in clinical safety and pharmacovigilance activities, including evidence generation, benefit‑risk assessment, causality assessment and evaluation of safety signals.
* Experience developing and executing safety strategies for products in clinical development.
* Experience with international pharmacovigilance requirements and drug development and approval processes (e.g., ICH, GVP modules, CIOMS initiatives).
* Experience leading large matrix organizations and cross‑functional teams.
Preferred Qualification
* Experience developing and executing safety strategies for products in clinical development, preferably in Oncology.
* Proven record of high‑quality, timely decision‑making and creative problem‑solving in complex or critical safety situations.
* Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees.
* Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to external pharmacovigilance or industry initiatives.
* Excellent verbal and written communication skills, with the ability to influence senior internal and external stakeholders and drive change to implementation.
* Resilience and adaptability, with the ability to adjust priorities in a changing environment while maintaining focus on patient safety and risk reduction.
Benefits
* Health care and other insurance benefits for employee and family.
* Retirement benefits.
* Paid holidays and vacation.
* Paid caregiver/parental and medical leave.
Accommodations for Applicants
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at usrecruitment.adjustments@gsk.com.
Equal Opportunity Employer
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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