SERM Scientific Director - #2084957

442153

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

Position Summary

Provides advanced scientific expertise in the safety evaluation and risk management of key GSK oncology assets in clinical development. Leads the identification, assessment, and communication of safety risks to ensure robust benefit-risk profiles and protection of patients globally.

This role plays a critical part in shaping the safety strategy of innovative oncology therapies, partnering cross-functionally to enable high-quality, timely decision-making and proactive risk mitigation across the portfolio.

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 programmes
• Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs)
• Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
• Ensure high-quality, timely delivery while managing multiple priorities

• 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 for and contribute to Safety Review Team (SRT) meetings
• Escalate emerging safety issues to senior leadership and governance bodies as appropriate
• Build strong working relationships and lead effectively within a global matrix organisation
• Coach and mentor colleagues as appropriate

• Present safety recommendations and emerging risks to senior governance committees
• 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 the development of long-term safety and clinical programme strategies
• Identify opportunities for continuous improvement and innovation in safety evaluation processes
• Communicate complex scientific information clearly to a range of audiences

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree in a health-related discipline (e.g., Life Sciences, Pharmacy, Medicine, Nursing), with significant relevant experience
• Substantial experience in pharmacovigilance, drug safety, or a related function within the pharmaceutical or biotechnology industry
• Experience supporting safety in oncology clinical development programmes
• Strong expertise in:

• Signal detection and risk assessment
• Clinical trial safety oversight
• Regulatory safety documentation and submissions

• Knowledge of global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
• Proven ability to work effectively in a complex, global matrix environment
• Strong analytical, communication, and problem-solving skills

Preferred Qualification

If you have the following characteristics, it would be a plus:

• Advanced degree (e.g., PhD, PharmD, MD or equivalent)
• Experience interacting with global regulatory authorities
• Experience presenting to senior governance or safety review committees
• Demonstrated leadership experience, including mentoring or team leadership in a matrix setting
• Track record of influencing cross-functional teams and contributing to strategic decision-making
• Experience supporting late-stage clinical development programmes

Working arrangement

This is a hybrid role based in the United Kingdom with a mix of office and remote working. Some travel may be required for meetings and regulatory interactions.

What we value

We seek people who work with integrity, focus on patients and collaborate respectfully. We welcome different perspectives and promote inclusion in our teams. We support development and learning so you can grow while making a meaningful impact on patient safety.

Apply now

If you are ready to use your scientific expertise to protect patients and shape global safety strategy, we would like to hear from you. Please submit your CV and a short cover letter explaining what motivates you to take on this role.Belgium Salary Range / Fourchette salariale - Belgique: EUR 111,750 to EUR 186,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are

also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.

Why GSK?

Uniting science, technology and talent to get ahead of disease...