Senior Scientific Director, Oncology
National Society for Black Engineers · Collegeville, PA
FULL-TIME
Posted Jun 27, 2026
217K–363K a year
Job Description
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. The 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
• 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
Basic Qualification
• 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 biotechnological 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
• Prior leadership experience in a global safety or pharmacovigilance 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
Salary & Benefits
Annual base salary ranges from $217,800 to $363,000 depending on location and experience. The role offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program, along with comprehensive health care, retirement, paid holiday, vacation, and paid caregiver/parental leave benefits.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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. The 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
• 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
Basic Qualification
• 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 biotechnological 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
• Prior leadership experience in a global safety or pharmacovigilance 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
Salary & Benefits
Annual base salary ranges from $217,800 to $363,000 depending on location and experience. The role offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program, along with comprehensive health care, retirement, paid holiday, vacation, and paid caregiver/parental leave benefits.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
Benefits
- Paid time off
- Health insurance
- Dental insurance
Additional Details
- City
- Collegeville
- State
- Pennsylvania
- Country
- US
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