SERM Medical Director, Oncology
Location: London, United Kingdom; Poznan, Poland; Warsaw, Poland
Department: Medical and Clinical
Job ID: 414990
Employment Type: Full Time
Job Purpose:
Provide in-depth medical/scientific expertise in safety evaluation and risk management of key GSK assets in clinical development and/or post-marketing settings.
Ensure scientifically sound review, interpretation of data, and management of safety issues, escalating when appropriate.
Recommend further characterization, management, and communication of safety risks.
Support pharmacovigilance and benefit-risk management to ensure global patient safety.
If appointed as a manager, lead a team of individual contributors through resource and team management, coaching, collaboration, decision-making, change management, and stakeholder relationship management.
Key Responsibilities:
Scientific/Medical Knowledge and PV Expertise:
Lead pharmacovigilance and risk management planning.
Develop strategies for issue evaluation in the clinical matrix.
Lead safety components of global regulatory submissions.
Conduct expert literature review, clinical data synthesis, analysis, and interpretation.
Make quality decisions based on comprehensive data assessment.
Demonstrate multitasking, prioritization, and high-performance standards.
Explore alternatives to reach mutually beneficial solutions.
Cross-functional Matrix Team Leadership:
Lead safety governance and the execution of safety strategies for products.
Facilitate safety governance and Safety Review Teams (SRTs) in clinical and post-marketing settings.
Represent Global Safety on Clinical Matrix Teams and Project Teams.
Lead cross-functional teams addressing urgent product safety issues.
Drive process initiatives to enhance regulatory adherence, quality, and operational efficiency.
Author standard operating procedures (SOPs) updates.
Escalate safety issues and ensure clear communication within governance structures.
Build strong working relationships and provide coaching and mentorship.
Communications and Influencing:
Present recommendations and safety issues to GSK Senior Governance Committees.
Interact confidently and influence at all organizational levels.
Represent GSK in regulatory authority meetings and partner company discussions.
Lead cross-functional process improvement initiatives.
Strategically contribute to clinical program developments.
Regularly propose innovative ideas for process improvements.
Prepare and support audits/inspections, ensuring inspection readiness.
Basic Qualifications:
Primary medical qualification (MBBS or equivalent) with Specialty Training completion (CCT, fellowship, or equivalent).
Clinical background/experience.
Knowledge of international pharmacovigilance regulations (e.g., ICH, GVP modules, CIOMS) and drug development processes.
Preferred Qualifications:
PhD, PharmD, or MPH in addition to medical degree and certification.
Why GSK?
At GSK, we unite science, technology, and talent to get ahead of disease together. We work to positively impact global health and deliver sustainable shareholder returns while fostering a workplace where people thrive.
Focus on vaccines, specialty and general medicines.
Specialize in infectious diseases, HIV, respiratory/immunology, and oncology.
Emphasize a welcoming, inclusive, and growth-oriented environment.
GSK is an Equal Opportunity Employer. We value diversity and provide reasonable accommodations during the recruitment process if needed.
Important Notices:
GSK does not accept referrals from employment agencies/businesses without prior written authorization.
US Licensed Healthcare Professionals: GSK may capture and report expenses incurred during interviews to comply with federal and state transparency requirements.
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