Senior Oncology Safety & Medical Director (SERM)

Glaxosmithkline; Durham (NC); Hybride; USD 223 000 - 371 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement benefits

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Medical degree

GMC registration eligibility

Postgraduate training

Pharmacovigilance experience

Drug safety expertise

Clinical development knowledge

Regulatory submissions experience

Cross-functional collaboration

Communication skills

Formation

Postgraduate clinical training

Description du poste

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.