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- Tasks: Lead medical strategy for late-phase clinical development and oversee global trials.
- Company: Join a dynamic clinical-stage Biotech making waves in the industry.
- Benefits: Enjoy a high-impact role with opportunities for leadership and professional growth.
- Why this job: Be part of a passionate team driving innovation and making a real difference in healthcare.
- Qualifications: Must be a qualified physician with 10+ years in clinical development and strong regulatory experience.
- Other info: Ideal for strategic thinkers ready to shape the future of medicine.
The predicted salary is between 72000 - 108000 £ per year.
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!
Contact Detail:
AL Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Director
✨Tip Number 1
Network with professionals in the biotech and pharmaceutical industries, especially those who have experience in clinical development. Attend industry conferences or seminars where you can meet potential colleagues and learn about the latest trends in late-phase development.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for NDA/BLA submissions in both the FDA and EMA. Understanding these processes will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences leading global trials and how you managed cross-functional teams. Be ready to provide examples of how you ensured GCP compliance and handled safety data oversight.
✨Tip Number 4
Showcase your strategic thinking skills by being prepared to discuss how you would align clinical strategies with broader company goals. Think about how your leadership style can foster collaboration among diverse teams.
We think you need these skills to ace Senior Medical Director
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in clinical development, particularly in Phase 3 programs. Emphasise your leadership roles and any specific achievements that align with the responsibilities of a Senior Medical Director.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strategic thinking and scientific foundation. Discuss your experience with global trials and regulatory submissions, and explain how your background makes you a perfect fit for this role.
Highlight Key Skills: In your application, clearly outline your knowledge of GCP, ICH guidelines, and pharmacovigilance. Mention your ability to interpret complex data and your experience in matrix leadership, as these are crucial for the position.
Showcase Collaborative Experience: Provide examples of your cross-functional collaboration in previous roles. Highlight how you've worked with internal teams and external partners, as well as your experience in leading high-performing medical staff.
How to prepare for a job interview at AL Solutions
✨Showcase Your Leadership Experience
As a Senior Medical Director, you'll need to demonstrate your ability to lead teams effectively. Prepare specific examples of how you've successfully led clinical development programs and managed cross-functional teams in the past.
✨Understand Regulatory Requirements
Familiarise yourself with the regulatory landscape, especially regarding NDA/BLA submissions. Be ready to discuss your experience interfacing with regulatory agencies like the FDA and EMA, as this will be crucial for the role.
✨Highlight Your Strategic Thinking
This position requires a strategic mindset. Prepare to discuss how you've developed and implemented clinical strategies that align with broader organisational goals, showcasing your ability to think both critically and creatively.
✨Prepare for Technical Questions
Expect to be asked about GCP, ICH guidelines, and pharmacovigilance. Brush up on these topics and be ready to explain how you've applied this knowledge in your previous roles, particularly in late-phase development.
