SERM Senior Scientific Director

Business Introduction
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.
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Our approach to R&D

Position Summary

As a senior leader within Global Safety, the Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets. This role is accountable for driving safety strategy, enabling robust benefit-risk assessment, and ensuring the proactive identification, evaluation, and management of safety risks across both clinical development and post-marketing settings.

This position plays a critical role in protecting patient safety globally while influencing enterprise safety strategy and decision-making.

Key Responsibilities

Safety Strategy & Governance

• Define and drive the clinical safety and pharmacovigilance strategy for assigned oncology assets in alignment with global business objectives
• Lead safety governance activities, ensuring appropriate escalation, communication, and resolution of emerging safety issues
• Anticipate, identify, and address safety signals, ensuring effective and timely implementation of risk mitigation strategies
• Provide strategic recommendations on benefit-risk profiles to support development and lifecycle management decisions

Scientific Leadership & Decision-Making

• Exercise expert scientific judgment in the evaluation and interpretation of complex safety data
• Lead safety data analyses and signal detection activities, ensuring scientifically robust conclusions and documentation
• Guide causality assessments, benefit-risk evaluations, and safety evidence generation across the portfolio
• Serve as a recognized subject matter expert in pharmacovigilance methodologies and regulatory expectations

Signal Detection & Risk Management

• Oversee proactive identification and assessment of safety signals from clinical trials, post-marketing data, and real-world evidence
• Develop and implement risk management strategies, including labeling updates, risk minimization measures, and stakeholder communication plans
• Partner closely with safety physicians and cross-functional teams to ensure comprehensive safety oversight

Cross-Functional and line  Leadership

• Lead and influence global, matrixed teams to ensure alignment and execution of safety strategies
• Line manage physicians and scientists, including team structure, team development, and recruitment activities
• Build strong collaborative relationships across clinical, regulatory, medical, and commercial functions
• Contribute to due diligence activities, including safety assessments for business development opportunities
• Demonstrate agility and resilience in a dynamic, fast-paced environment

Regulatory & External Engagement

• Provide strategic oversight and input into regulatory safety documents and responses to Health Authorities
• Ensure compliance with global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
• Represent safety function in governance forums and external engagements as needed
• Drive clear, concise, and influential communication with internal and external stakeholders

Why You?

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

• Advanced degree in a relevant scientific or healthcare discipline (e.g., PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent)
• Significant experience (7+ years) in pharmacovigilance and drug safety within the pharmaceutical or biotech industry
• Deep expertise in clinical safety across drug development and post-marketing environments
• Demonstrated experience in:
  • Signal detection and evaluation
  • Benefit-risk assessment and safety decision-making
  • Risk management strategy development
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP, CIOMS)
• Experience working in complex, global matrix organizations
• Proven ability to influence decisions and lead safety strategy at a program or portfolio level

Preferred Qualification
If you have the following characteristics, it would be a plus:

• Prior leadership experience in a global SERM or safety function.
• Experience with regulatory interactions and inspections in the US and other regions.
• Familiarity with pharmacoepidemiology, real-world evidence, or biostatistics approaches.
• Experience preparing Development Core Safety Information, PBRERs or DSURs.
• Oncology therapeutic area expertise

• Experience leading global safety teams or major programs
• Experience interacting directly with Health Authorities and regulatory submissions
• Track record of influencing senior leadership and governance bodies
• Demonstrated success in mentoring and developing scientific talent

What we value in you
We seek people who act with patient focus, integrity and respect. You will be decisive and evidence-driven. You will build trusted relationships and support colleagues to do their best work. We welcome applicants from all backgrounds and encourage those who share our mission to apply.

How to apply
If this role fits your experience and ambitions, we would like to hear from you. Please submit your CV and a short cover note explaining your interest and how you meet the core requirements. We look forward to learning about you.

Skills

Digital Fluency, Enterprise Leadership, Influencing Without Authority, Pharmacovigilance, Presentation Techniques

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

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.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.

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