SERM Senior Scientific Director, Oncology

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.

Qualifications

• 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
• 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 regulatory submissions
• Track record of influencing senior leadership and governance bodies
• Demonstrated success in mentoring and developing scientific talent