Description
GSK is seeking a Scientific Director to provide advanced scientific expertise in the safety evaluation and risk management of key oncology assets in clinical development.
The Scientific Director will lead the identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally.
Key Responsibilities:
- Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
- Drive the evaluation and interpretation of safety data, including signal detection and assessment
- Develop strategic approaches for safety issue evaluation within clinical development programs
- Contribute to safety components of global regulatory submissions
- Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
- Ensure high-quality, timely delivery of outputs while managing multiple priorities
Cross-Functional Matrix Leadership:
- Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams
- Lead cross-functional efforts to address urgent and complex product safety issues
- Partner closely with Safety Physicians and stakeholders to prepare and present at Safety Review Team (SRT) meetings
- Escalate emerging safety issues to senior leadership and governance bodies as appropriate
- Build strong working relationships and effectively lead within a global matrix environment
- Mentor and coach junior team members as applicable
Communication, Influence, and Strategy:
- Present safety recommendations and emerging risks to senior governance committees with clarity and impact
- Represent GSK in interactions with regulatory authorities, external experts, and partners
- Apply strategic thinking to evaluate internal and external factors influencing safety decisions
- Contribute to long-term safety and clinical development strategies
- Drive continuous improvement by introducing innovative approaches to safety evaluation and processes
- Communicate complex scientific information effectively to diverse audiences
Basic Qualifications:
- Degree in a health or life sciences discipline (e.g., Bachelor of Science, PharmD, MD, PhD, or equivalent)
- Extensive experience in pharmacovigilance, drug safety, or related safety evaluation role in the pharmaceutical or biotech industry
- Practical experience in signal detection, safety surveillance and risk management across clinical development and post-marketing
- Knowledge of global pharmacovigilance requirements and drug development processes
- Strong clinical or scientific judgement with experience interpreting clinical and safety data
Preferred Qualification:
- Advanced degree (PharmD, PhD, MD) or equivalent clinical qualification
- 10 or more years of pharmacovigilance or medical safety experience
- Experience in preparing regulatory safety documents and participating in regulatory interactions
- Experience leading safety activities in a specific therapeutic area relevant to the role
- Demonstrated ability to lead and influence cross-functional teams in a matrix setting
- Experience supporting inspections, audits, and readiness activities
Salary Range: PLN 525,750 to PLN 876,250 (Poland) EUR 124,500 to EUR 207,500 (Italy) EUR 141,000 to EUR 235,000 (Belgium)