Job Title: Director of Scientific Affairs and Portfolio Management (Therapeutic Areas: Respiratory, Infectious Diseases/HIV, Hepatitis/Fibrosis, Neurology/Dementias). This position provides in-depth medical/scientific expertise in safety evaluation and risk management of key assets or in clinical development and/or post-marketing settings. It ensures scientifically sound review and interpretation of data and manages safety issues, escalating as appropriate. The role supports pharmacovigilance and benefit-risk management for the assigned portfolio to ensure Patient Safety globally.

Key Responsibilities

• Scientific/Medical Knowledge & PV Expertise
  • Lead Pharmacovigilance and Risk Management Planning and develop strategy for evaluation of issues in the clinical matrix.
  • Lead the safety component of global regulatory submissions.
  • Apply expert evaluation skills for literature review, clinical data synthesis, analysis and interpretation.
  • Demonstrate quality decision making and creative problem resolution based on assessment of supporting information and broader context.
  • Prioritise tasks and maintain high performance standards and timely delivery.
  • Explore positions and alternatives to reach mutually beneficial agreements and solutions.
• Cross-functional Matrix Team Leadership
  • Lead safety governance and risk-reduction strategies for products in clinical development and post-marketing settings.
  • Facilitate safety governance and cross-functional teams to detect/address safety issues and ensure risk-reduction in study protocols and labeling.
  • Represent GSK on cross-functional Clinical Matrix Teams/Project Teams and lead ad hoc teams on safety issues.
  • Lead or participate in process initiatives to improve adherence to regulations, data standards, quality and efficiency.
  • Author or contribute to written standards (e.g., SOPs) to ensure compliant practices.
  • Escalate safety issues and communicate with governance bodies; build and mentor a matrix-team style leadership.
• Communications & Influencing
  • Lead presentations on safety recommendations to senior staff and participate in meetings with regulators and external partners.
  • Drive cross-functional process improvements and contribute to long-term strategy for clinical programs.
  • Support inspection readiness and audits/inspections as needed.
  • Demonstrate excellent verbal and written communication and influencing skills.

Basic Qualifications

• Medical degree (for Medical Director) or PhD/PharmD for Scientist.
• Advanced experience in the pharmaceutical or biotech industry in Pharmacovigilance or Drug Safety.
• Significant pharmacovigilance experience related to safety evaluation and risk management in both clinical development and post-marketing activities.
• Experience with signal detection and safety surveillance.
• Knowledge/experience of international pharmacovigilance requirements (e.g., ICH, GVP modules, CIOMS) and drug development/approval processes.
• Experience working in large matrix organizations.

Why GSK?

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We focus on four therapeutic areas and are committed to an agile working culture. We strive to create an environment where our people can thrive and contribute to improving patient health. GSK is an Equal Opportunity Employer.

Contact & Support

If you require adjustments to our recruitment process, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391 (hours: 8.30am–12.00 noon, Mon–Fri; holidays may vary). This channel is for adjustments only; for other inquiries please refer to the UK Recruitment FAQ guide.

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Note: This job description reflects the responsibilities and qualifications currently required and is subject to change. This posting does not imply a job offer or guarantee of employment.

Seniority level: Not Applicable | Employment type: Full-time | Job function: Research, Analyst, and Information Technology | Industry: Pharmaceutical Manufacturing