SERM Medical Director, Oncology

GSK•Upper Providence, PA
•$222,750 - $371,250•Hybrid

About The Position

Provides medical and scientific leadership in the safety evaluation and risk management of GSK’s oncology assets in clinical development. The role interprets safety data, identifies and escalates safety signals, and delivers clear, evidence-based recommendations to support benefit–risk decisions. It contributes to global governance, protects patient safety, and helps shape the safety profile of innovative oncology medicines. The position leads pharmacovigilance and risk-management activities for assigned oncology assets and clinical trials; sets strategy for evaluating and managing safety issues throughout clinical development; and provides medical input to global regulatory submissions. It represents Safety on cross-functional teams, leads work on complex safety issues, and communicates recommendations to senior governance committees, regulators, external experts, and partners. This hybrid role is based in the United States. On-site attendance is expected for key meetings, governance activities, and team collaboration, with remote work supported for focused work and stakeholder engagement.

Requirements

  • Medical degree with current GMC registration or eligibility to practise in the UK, and relevant clinical experience.
  • Completion of formal postgraduate clinical training, such as 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 judgment and ability to deliver clear, evidence-based recommendations.

Nice To Haves

  • Postgraduate specialization 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 evaluating and managing safety issues across the clinical development lifecycle.
  • Analyze 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 clinical judgment to complex and sometimes conflicting data to inform benefit–risk decisions.
  • Escalate safety concerns promptly in accordance with governance processes.
  • Represent Safety on cross-functional Clinical Matrix and Project Teams.
  • Lead cross-functional teams addressing urgent and complex product safety issues.
  • Contribute to and, where appropriate, lead Safety Review Teams (SRTs).
  • Build collaborative relationships across functions and geographies.
  • Coach and mentor colleagues and contribute to organizational capability development.
  • Communicate and align effectively with Safety Leads, senior SERM leadership, and key stakeholders.
  • Present safety issues and recommendations to senior governance committees.
  • Influence decisions through clear, credible, evidence-based communication.
  • Represent GSK in interactions with regulatory authorities, external experts, and partners.
  • Contribute to safety strategy for clinical programmes and broader SERM activities.
  • Identify opportunities to improve processes, drive innovation, and enhance operational effectiveness.
  • Maintain strong awareness of the internal and external regulatory and scientific environment.

Benefits

  • Annual bonus.
  • Eligibility to participate in a share-based long-term incentive program, dependent on role level.
  • Health care and other insurance benefits for employees and family.
  • Retirement benefits.
  • Paid holidays.
  • Vacation.
  • Paid caregiver, parental, and medical leave.

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What This Job Offers

Job Type

Full-time

Career Level

Director

Education Level

Ph.D. or professional degree

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