SERM Senior Medical Director, Oncology

SERM Senior Medical Director, Oncology

At GSK, we have bold ambitions for patients, aiming 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, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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 and supporting their development across the portfolio.

Responsibilities

• Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefitrisk assessment, regulatory submissions and proactive risk-management strategies.
• Oversee the review, interpretation and communication of safety data; identify, escalate 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 within 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.

Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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, benefitrisk 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 (for example ICH, GVP modules, CIOMS initiatives).
• Experience of 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.
• Experience with successful global regulatory filings (e.g., IND/CTA, NDA/BLA, and EMA/MHRA MAAs).
• 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.

Working Model

This role is hybrid. You will be expected to work on site at a US office a minimum of two days per week, with flexibility for remote work for the remainder.

Skills

Clinical Development, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, Strategic Thinking

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.