Description
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.
Responsibilities
- Provide expert leadership in clinical safety and pharmacovigilance for oncology assets, including signal evaluation, benefit–risk assessment, regulatory submissions 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.
Basic Qualification
- 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.
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave