Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit-risk assessment and proactive risk-management strategies.
Oversee the review, interpretation and communication of safety data; identify, escalate and manage safety issues through established safety governance forums.
Develop and implement safety strategies, policies and processes aligned with Global Safety operational and strategic plans.
Coach and mentor medical and scientific colleagues in SERM in signal evaluation, risk management, and preparation of regulatory safety deliverables.
Lead within a global, cross-functional matrix, building strong collaborative relationships and influencing internal and external stakeholders on safety topics.
Lead or oversee SERM safety input into due diligence and other key strategic activities, ensuring safety perspectives shape decision-making.
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Medical degree, with completion of a formal postgraduate clinical training, residency or specialty training
Experience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety.
Experience in clinical safety and pharmacovigilance activities, including evidence generation, benefit-risk assessment, causality assessment and evaluation of safety signals.
Experience developing and executing safety strategies for products in clinical development.
Experience with international pharmacovigilance requirements and drug development and approval processes (for example ICH, GVP modules, CIOMS initiatives).
Experience of leading large matrix organizations and cross-functional teams.
Preferred Qualification
Experience developing and executing safety strategies for products in clinical development, preferably in Oncology
Proven record of high-quality, timely decision-making and creative problem-solving in complex or critical safety situations.
Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees.
Recognised expertise in pharmacovigilance regulations and methodologies, and experience contributing to external pharmacovigilance or industry initiatives.
Excellent verbal and written communication skills, with the ability to influence senior internal and external stakeholders and drive change to implementation.
Resilience and adaptability, with the ability to adjust priorities in a changing environment while maintaining focus on patient safety and risk reduction.
How we work and what we value
We put patients first and act with transparency and integrity. We value clear communication, teamwork, and practical problem solving. We welcome applicants from all backgrounds and support inclusion. We look for people who want to make a meaningful impact on patient health.
Ready to make a difference?
If this role speaks to you, please apply now. We look forward to learning how your experience and perspective can help us get ahead of disease together.
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $284,625 to $474,375. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.
Benefits
Health insurancePerformance bonus
Additional Information
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.
Find out more:
Our approach to R&D
Position Summary
As SERM Senior Medical Director, Oncology, you will lead clinical safety and pharmacovigilance strategy for oncology assets within Global Safety.
You will oversee rigorous review, interpretation and communication of safety data, ensuring timely identification, escalation and management of safety issues.
Working in a global, cross-functional matrix, you will collaborate with senior governance and partner teams to drive evidence-based safety decisions. You will also mentor SERM colleagues, strengthening safety and risk-management capabilities and supporting their development across the portfolio.
Gsk · - Pennsylvania - Upper Providence