Job Description
George Higginson is currently partnering with a high-growth, clinical-stage biotech seeking an Executive Director of Drug Safety & PV to lead global safety strategy across late-stage clinical development and regulatory milestones.
This is a visible, enterprise-level leadership role for a Qualified Physician with deep Phase III and regulatory submission experience, operating as the senior safety authority across the organisation.
As Executive Director, you will own and shape global PV strategy, acting as the senior safety voice to executive leadership, development teams, and regulators.
Key Responsibilities:
* Set and lead global Drug Safety & PV strategy across late-stage assets
* Serve as executive safety lead for Phase III programs and filings
* Oversee signal detection, benefit–risk assessment, and risk management frameworks
* Act as senior medical reviewer for complex safety issues and escalations
* Lead safety content for BLA / MAA submissions and regulatory interactions
* Chair or represent Drug Safety on governance committees (DSC / DSMB interface)
* Own Risk Management Plans and global safety oversight models
* Build, mentor, and guide Drug Safety leadership and external vendors
* Partner closely with Clinical, Regulatory, Medical, and Commercial leadership
Your Background:
* Qualified Physician (GMC registered or GMC-permissible)
* 15+ years’ experience in Drug Safety / Pharmacovigilance
* Demonstrated leadership of Phase III programs and regulatory submissions
* Proven experience presenting safety data to regulators and senior governance bodies
* Deep knowledge of UK / EU / US PV regulations
* Therapeutic experience in immunology, dermatology, rheumatology, or GI preferred
* Comfortable operating at executive, board-adjacent level in a biotech environment
Why This Role?
This is a rare opportunity to step into a true executive Drug Safety role at a pivotal inflection point, where safety strategy directly influences regulatory success, pipeline value, and patient impact.
Interested in a confidential conversation?
Apply directly or message George Higginson to discuss further.