Position: Senior Medical Director
Location: Cambridge, United Kingdom
George Higginson is currently searching for an experienced Senior Medical Director to play a pivotal leadership role in advancing a Clinical-stage Biotech's clinical development programs through late-stage development. Reporting to the Chief Medical Officer, you’ll provide medical oversight across global trials, contribute to regulatory strategy, and ensure GCP compliance throughout. This is a high-impact role for a strategic clinical leader who thrives in a fast-paced, cross-functional environment.
Main Responsibilities:
* Lead the medical content and strategy across late-phase development programs.
* Provide clinical and scientific leadership to internal teams and external partners (e.g. CROs, consultants).
* Ensure robust medical oversight of studies and safety data, in collaboration with PV and Clinical Operations.
* Act as a key contributor to regulatory submissions (NDA/BLA) and represent the company in Health Authority meetings.
* Serve as deputy to the CMO when required, and a core member of the Drug Safety Committee.
* Oversee medical input on protocol design, study conduct, data review, and benefit-risk assessments.
* Collaborate closely with Medical Affairs and Commercial to align clinical strategy with broader goals.
* Recruit, lead, and develop high-performing medical staff as needed.
Requirements:
* Qualified physician (GMC registered or eligible).
* 10+ years of experience in clinical development with a strong focus on Phase 3 programs.
* Proven track record of leading global trials and interfacing with regulatory agencies (FDA/EMA).
* Strong knowledge of GCP, ICH guidelines, and pharmacovigilance.
* Skilled at interpreting complex data and making informed, strategic decisions.
* Experienced in matrix leadership and cross-functional collaboration.
'Nice-to-haves':
* Background in Dermatology or Rheumatology.
* Experience with Biologics and/or Immunology.
* Prior involvement in NDA/BLA or MAA submissions.
What We’re Looking For:
* A strategic thinker with a strong scientific foundation and operational awareness.
* A collaborative leader and effective communicator, comfortable operating at executive level.
* A hands-on contributor who can switch seamlessly between big-picture planning and day-to-day execution.
This is a fantastic opportunity to be a key part of a true-underdog clinical-stage Biotech, soon approaching a BLA submission.
Apply today to take the next step in your leadership journey!