Position Summary
As SERM Senior Medical Director, Oncology, lead clinical safety and pharmacovigilance strategy for oncology assets within Global Safety. Oversee review, interpretation, and communication of safety data; ensure timely identification, escalation, and management of safety issues. Collaborate in a global, cross-functional matrix and mentor SERM colleagues.
Responsibilities
- Provide expert clinical safety/pharmacovigilance leadership for oncology assets (signal evaluation, benefit–risk assessment, regulatory submissions, proactive risk management).
- Oversee safety data review/interpretation/communication; identify, escalate, and manage safety issues through safety governance forums.
- Develop and implement safety strategies, policies, and processes aligned to Global Safety plans.
- Coach and mentor colleagues on signal evaluation, risk management, and regulatory safety deliverables.
- Lead matrix collaboration and influence internal/external stakeholders on safety topics.
- Lead/oversee SERM safety input into due diligence and strategic activities to shape decisions.
Qualifications
Required:
- Medical degree with completed formal postgraduate clinical training/residency/specialty training.
- PV/drug safety experience in pharma/biotech.
- Clinical safety/PV experience (evidence generation, benefit–risk, causality, safety signal evaluation).
- Experience developing/executing safety strategies for products in clinical development.
- Familiarity with international PV requirements and drug development/approval processes (e.g., ICH, GVP, CIOMS).
- Experience leading large matrix organizations and cross-functional teams.
Preferred:
- Oncology-focused safety strategy experience for clinical development products.
- Track record of timely decision-making and problem-solving in critical safety situations.
- Experience with safety governance (e.g., advisory panels, senior governance committees).
- Experience with successful global regulatory filings.
- Recognized PV expertise; external PV/industry initiative contribution.
- Excellent communication skills; influence senior stakeholders.
- Resilience/adaptability with focus on patient safety and risk reduction.
Working Model
Hybrid: on-site at a US office at least two days/week; remote for the remainder.