Define and drive the clinical safety and pharmacovigilance strategy for assigned oncology assets in alignment with global business objectives
Lead safety governance activities, ensuring appropriate escalation, communication, and resolution of emerging safety issues
Anticipate, identify, and address safety signals, ensuring effective and timely implementation of risk mitigation strategies
Provide strategic recommendations on benefit-risk profiles to support development and lifecycle management decisions
Scientific Leadership & Decision-Making
Exercise expert scientific judgment in the evaluation and interpretation of complex safety data
Lead safety data analyses and signal detection activities, ensuring scientifically robust conclusions and documentation
Guide causality assessments, benefit-risk evaluations, and safety evidence generation across the portfolio
Serve as a recognized subject matter expert in pharmacovigilance methodologies and regulatory expectations
Signal Detection & Risk Management
Oversee proactive identification and assessment of safety signals from clinical trials, post-marketing data, and real-world evidence
Develop and implement risk management strategies, including labeling updates, risk minimization measures, and stakeholder communication plans
Partner closely with safety physicians and cross-functional teams to ensure comprehensive safety oversight
Cross-Functional Leadership
Lead and influence global, matrixed teams to ensure alignment and execution of safety strategies
Build strong collaborative relationships across clinical, regulatory, medical, and commercial functions
Contribute to due diligence activities, including safety assessments for business development opportunities
Demonstrate agility and resilience in a dynamic, fast-paced environment
Regulatory & External Engagement
Provide strategic oversight and input into regulatory safety documents and responses to Health Authorities
Ensure compliance with global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
Represent safety function in governance forums and external engagements as needed
Drive clear, concise, and influential communication with internal and external stakeholders
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Advanced degree in a relevant scientific or healthcare discipline (e.g., PhD, PharmD, RN/BSN/MSN, NP, RPh, or equivalent)
Significant experience (7+ years) in pharmacovigilance and drug safety within the pharmaceutical or biotech industry
Deep expertise in clinical safety across drug development and post-marketing environments
Demonstrated experience in: Signal detection and evaluation
Benefit-risk assessment and safety decision-making
Risk management strategy development
Strong knowledge of global pharmacovigilance regulations (ICH, GVP, CIOMS)
Experience working in complex, global matrix organizations
Proven ability to influence decisions and lead safety strategy at a program or portfolio level
Preferred Qualification
If you have the following characteristics, it would be a plus:
Prior leadership experience in a global SERM or safety function.
Experience with regulatory interactions and inspections in the US and other regions.
Familiarity with pharmacoepidemiology, real-world evidence, or biostatistics approaches.
Experience preparing Development Core Safety Information, PBRERs or DSURs.
Oncology therapeutic area expertise
Experience leading global safety teams or major programs
Experience interacting directly with Health Authorities and
Benefits
Health insurance
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 a senior leader within Global Safety, the Senior Scientific Director, Clinical Safety (Oncology) provides strategic scientific leadership and oversight of clinical safety and pharmacovigilance activities across assigned oncology assets. This role is accountable for driving safety strategy, enabling robust benefit-risk assessment, and ensuring the proactive identification, evaluation, and management of safety risks across both clinical development and post-marketing settings.
This position plays a critical role in protecting patient safety globally while influencing enterprise safety strategy and decision-making.
Gsk · - Pennsylvania - Upper Providence