Oncology SERM Medical Director - Hybrid/Remote

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

Benefits offered by this job

Annual bonus

Long-term incentive program

Health care and insurance benefits

Retirement benefits

Paid holidays and leave

Job summary

GSK is seeking a Medical/Pharmacovigilance leader to provide science-driven safety leadership in oncology development. You will steer safety strategies across clinical programs, collaborate in a global matrix, and influence governance with evidence-based recommendations.

You will shape safety strategy for innovative oncology medicines, engage with governance, and contribute to regulatory submissions while working in a hybrid US-based setting. This role offers significant global impact.

Qualifications

• Medical degree with GMC registration (or eligibility to practise in the UK) and relevant clinical experience.
• 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.
• Postgraduate specialisation in 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 major programmes.
• Prior engagement with regulatory authorities and external safety forums.
• Demonstrated ability to coach and develop colleagues in medical, scientific, or safety roles.

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.
• Actively contribute to and, where appropriate, lead Safety Review Teams (SRTs).
• Build strong, collaborative relationships across functions and geographies.
• 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.

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

Scientific Presentations

Education

Medical degree with GMC registration

Postgraduate clinical training

Pharmacovigilance/Drug safety experience

Job description

GSK is seeking a Medical/Pharmacovigilance leader to provide science-driven safety leadership in oncology development. You will steer safety strategies across clinical programs, collaborate in a global matrix, and influence governance with evidence-based recommendations.

You will shape safety strategy for innovative oncology medicines, engage with governance, and contribute to regulatory submissions while working in a hybrid US-based setting. This role offers significant global impact.