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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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 Leadership

Lead and influence global, matrixed teams to ensure alignment and execution of safety strategies
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

Ready to apply?
If this role aligns with your skills and ambition, please submit your application. We look forward to learning how you can help us get ahead of disease together.

#LI-GSK

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $217,800 to $363,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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

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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SERM Senior Scientific Director, Oncology

GSK

Job Description

Safety Strategy & Governance

Scientific Leadership & Decision-Making

Signal Detection & Risk Management

Cross-Functional Leadership

Regulatory & External Engagement

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Job Details