Gsk
Pharmaceutical
SERMSeniorScientificDirector,Oncology
Neural analysis suggests this role is
optimal for Senior candidates.
“SERM Senior Scientific Director, Oncology at Gsk. Skills: Clinical safety, Pharmacovigilance, Risk management, Safety strategy. Define clinical safety strategy. Drive clinical safety strategy”
Industry & Context.
Benefit-risk assessment; Signal detection; Risk management
What They're Looking For.
Must Have
Advanced degree in scientific or healthcare discipline, 7+ years in pharmacovigilance and drug safety, Deep expertise in clinical safety, Signal detection and evaluation experience, Benefit-risk assessment experience, Risk management strategy development experience, Knowledge of global pharmacovigilance regulations, Experience in complex, global matrix organizations, Ability to influence decisions and lead safety strategy
Nice to Have
Prior leadership experience in global SERM or safety function, Experience with regulatory interactions and inspections, Familiarity with pharmacoepidemiology, Familiarity with real-world evidence, Familiarity with biostatistics approaches, Experience preparing Development Core Safety Information, Experience preparing PBRERs, Experience preparing DSURs, Oncology therapeutic area expertise, Experience leading global safety teams, Experience leading major programs, Experience interacting directly with Health Authorities, Experience with regulatory submissions, Track record of influencing senior leadership, Track record of influencing governance bodies, Success in mentoring scientific talent, Success in developing scientific talent
What You'll Do.
Define clinical safety strategy
Drive clinical safety strategy
Define pharmacovigilance strategy
Drive pharmacovigilance strategy
Lead safety governance activities
Ensure escalation of safety issues
Ensure communication of safety issues
Ensure resolution of safety issues
Anticipate safety signals
Identify safety signals
Address safety signals
Implement risk mitigation strategies
Provide recommendations on benefit-risk profiles
Support development decisions
Support lifecycle management decisions
Exercise scientific judgment
Interpret safety data
Lead safety data analyses
Lead signal detection activities
Ensure scientifically robust conclusions
Ensure documentation of conclusions
Guide causality assessments
Guide benefit-risk evaluations
Guide safety evidence generation
Oversee proactive identification of safety signals
Oversee assessment of safety signals
Develop risk management strategies
Implement risk management strategies
Implement risk minimization measures
Develop stakeholder communication plans
Partner with safety physicians
Partner with cross-functional teams
Ensure comprehensive safety oversight
Influence global teams
Ensure alignment of safety strategies
Ensure execution of safety strategies
Build collaborative relationships
Contribute to due diligence activities
Provide strategic oversight into regulatory safety documents
Provide input into regulatory safety documents
Provide strategic oversight into responses to Health Authorities
Provide input into responses to Health Authorities
Ensure compliance with global pharmacovigilance regulations
Represent safety function in governance forums
Represent safety function in external engagements
Drive clear communication
Drive concise communication
Drive influential communication
How You'll Work.
Team & Collaboration
Global, matrixed teams; Cross-functional teams; Clinical teams; Regulatory teams; Medical teams; Commercial teams
Communication Scope
Influential communication
Full Job Description
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](https://www.gsk.com/en-gb/innovation/) 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. Key Responsibilities ### **Safety Strategy & Governance** * 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
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