SERM Medical Director, Oncology

GlaxoSmithKline; Durham (NC); Hybrid; USD 223,000 - 371,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Job summary

GSK in the United States is seeking a Senior Pharmacovigilance Leader to drive safety evaluation and risk management for oncology assets in clinical development. The role requires leading safety activities across the development lifecycle and delivering evidence-based recommendations to protect patients.

You will shape safety strategies, lead cross-functional teams, and interact with regulatory authorities, ensuring governance and high-quality safety science in a global matrix environment.

Qualifications

• Medical degree with GMC registration or eligibility to practise in the UK.
• Completion of formal postgraduate clinical training (e.g., residency or specialty training).
• Significant experience in pharmacovigilance, drug safety or medical affairs.
• Demonstrated expertise in signal detection, evaluation, and risk management.
• Strong understanding of clinical development and post-marketing safety processes.
• Experience working effectively in matrixed, cross-functional environments.
• Excellent written and verbal communication skills, including preparation of medical and regulatory documents.
• Strong clinical judgement and the ability to deliver clear, evidence-based recommendations.

Responsibilities

• Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials.
• Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle.
• Analyse and interpret clinical data, literature, and emerging evidence to identify and assess safety signals.
• Provide expert medical input into the safety components of global regulatory submissions.
• Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit‑risk decisions.
• Ensure timely escalation of safety concerns in line with governance processes.
• Represent Safety on cross‑functional Clinical Matrix and Project Teams.
• Lead cross‑functional teams to address urgent and complex product safety issues.
• Coach and mentor colleagues, contributing to capability development within the organisation.
• Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders.
• Lead presentations on safety issues and recommendations to senior governance committees.
• Influence decision‑making through clear, credible, and evidence‑based communication.
• Represent GSK in interactions with regulatory authorities, external experts, and partners.
• Contribute to the development of safety strategy for clinical programmes and broader SERM activities.
• Identify opportunities to improve processes, drive innovation, and enhance operational effectiveness.
• Operate with strong awareness of the internal and external regulatory and scientific environment.

Skills

Medical degree

GMC registration eligibility

Postgraduate training

Pharmacovigilance experience

Drug safety expertise

Clinical development knowledge

Regulatory submissions experience

Cross-functional collaboration

Communication skills

Education

Postgraduate clinical training

Job description

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.

Find out more:

Our approach to R&D

Position Summary

Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development.

Responsible for the interpretation of safety data, identification and escalation of safety signals, and delivery of clear, evidence‑based recommendations to support benefit‑risk decisions. This role contributes to global governance and plays a critical part in protecting patient safety and shaping the safety profile of innovative oncology medicines.

Key Responsibilities

Scientific / Medical & Pharmacovigilance Expertise

• Lead pharmacovigilance and risk management activities for assigned oncology assets and clinical trials

• Define and drive strategy for the evaluation and management of safety issues across the clinical development lifecycle

• Analyseand interpret clinical data, literature, and emerging evidence toidentifyand assess safety signals

• Provide expert medical input into the safety components of global regulatory submissions

• Apply sound clinical judgement to complex and sometimes conflicting data sets to inform benefit‑risk decisions

• Ensuretimelyescalation of safety concerns in line with governance processes

Matrix Leadership & Cross‑functional Collaboration

• Represent Safety on cross‑functional Clinical Matrix and Project Teams

• Lead cross‑functional teams to address urgent and complex product safety issues

• Actively contribute to and, whereappropriate, lead Safety Review Teams (SRTs)

• Build strong, collaborative relationships across functions and geographies

• Coach and mentor colleagues, contributing to capability development within theorganisation

• Ensure effective communication and alignment with Safety Leads, senior SERM leadership, and key stakeholders

Communication, Influence & Governance

• Lead presentations on safety issues and recommendations to senior governance committees

• Influence decision‑making through clear, credible, and evidence‑based communication

• Represent GSK in interactions with regulatory authorities, external experts, and partners

• Contribute to the development of safety strategy for clinicalprogrammesand broader SERM activities

• Identifyopportunities to improve processes, drive innovation, and enhance operational effectiveness

• Operate with strong awareness of the internal and external regulatory and scientific environment

Why Join Us?

This is an opportunity to play a pivotal role in advancing GSK’s oncology pipeline, withdirectimpact on patient safety and global health outcomes.

You will:

• Shape the safety strategy of innovative oncology medicines

• Engage with senior governance and influence key development decisions

• Work within a highly collaborative, global matrix environment

• Contribute to scientific excellence and continuous improvement in safety science

Basic Qualifications

• Medical degree with current GMC registration (or eligibility topractisein the UK) and relevant clinical experience

• Completion of formal postgraduate clinical training (e.g., residency or specialty training)

• Significant experiencein pharmacovigilance, drug safety, or medical affairs

• Demonstratedexpertisein signal detection, evaluation, and risk management

• Strong understanding of clinical development and post‑marketing safety processes

• Experience working effectively in matrixed, cross‑functional environments

• Excellent written and verbal communication skills, including preparation of medical and regulatory documents

• Strong clinical judgement and the ability to deliver clear, evidence‑based recommendations

Preferred Qualifications

• Postgraduatespecialisationin a clinical discipline or pharmaceutical medicine

• Experience contributing to regulatory submissions and periodic safety reports

• Knowledge of epidemiology, biostatistics, or real‑world evidence relevant to safety assessment

• Experience leading Safety Review Teams or acting as safety lead for majorprogrammes

• Prior engagement with regulatory authorities and external safety forums

• Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles

Working Model

This role is hybrid, based in the United States. You will be expected on site for key meetings, governance activities and team collaboration. Remote working is supported to balance focused work and stakeholder engagement.

Skills

• Analytical Thinking
• Clinical Data Interpretation
• Clinical Development
• Clinical Pharmacology
• Clinical Trial Designs
• Clinical Trials Monitoring
• Digital Fluency
• Drug Regulatory Affairs
• Evidence Based Decision Making
• Executive Presence
• Hematology and Oncology
• Learning Agility
• Matrix Leadership
• Real World Evidence (RWE)
• Scientific Presentations*

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 $222,750 to $371,250. 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.

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.

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 [e-mail]

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.