Medical Director

Simbec-Orion Group; United Kingdom; Remote; GBP 90,000 - 130,000; Full time

Job summary

A leading company in clinical development is seeking a Medical Director to oversee the Medical Department. This role involves ensuring compliance with regulations, managing clinical trials, and collaborating with various teams to enhance patient safety and data integrity.

Qualifications

• Experience in medical monitoring and safety review within clinical research.
• Leadership experience in a Medical or Safety Department.

Responsibilities

• Lead and manage the Medical Department, ensuring quality and compliance.
• Serve as the point of contact for medical and safety issues.
• Participate in all stages of the clinical trial development process.

Skills

Leadership

Communication

Presentation

Financial Project Management

Medical Monitoring

Safety Review

Education

Medical Degree

Post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine

Tools

Electronic Data Systems

MS Office

Job description

Our Mission

Our passion for improving patients’ lives motivates us to apply our skills, experience, and knowledge to advance medicine.

We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.

The Role

We are looking for a Medical Director to join our Medical - Clinical Development team. You will lead and manage the Medical Department, ensuring that clinical trials are conducted with the highest regard for subjects' rights, safety, and wellbeing, and that the data collected is reliable. You will assume medical responsibility for clinical studies conducted by Simbec-Orion and provide interpretation of clinical data.

You will collaborate with cross-departmental teams (e.g., clinical operations, project management, pharmacovigilance, business development, biometrics, regulatory, and technical writing) to promote best practices across the organization.

Key Accountabilities

1. Lead and manage the Medical Department, ensuring quality and compliance with SOPs.
2. Serve as the point of contact for internal and external stakeholders regarding medical and safety issues.
3. Regularly review departmental SOPs to ensure compliance with current regulations and guidelines.
4. Act as Medical Monitor for assigned trials.
5. Participate in all stages of the clinical trial development process, including feasibility, protocol design, site selection, medical monitoring, AE and SAE management, and meetings.
6. Respond to audit queries and ensure timely resolution.
7. Generate medical and patient narratives and safety update reports.
8. Address CAPAs, escalations, and audit findings during departmental meetings.
9. Provide therapeutic area support, including internal training and review of proposals.
10. Stay updated on trends and regulations relevant to our projects.
11. Develop relationships with Key Opinion Leaders and investigators for ongoing studies and business development.
12. Support pharmacovigilance activities, including reviewing safety reports and identifying safety trends.
13. Ensure clinical trials meet all regulatory and ethical standards.
14. Assist in business development, including proposals and bid meetings.
15. Liaise with other functions to ensure client satisfaction.
16. Review and oversee departmental budget.

Skills Required

Essential

• Medical Degree
• Experience in medical monitoring and safety review within clinical research
• Leadership experience in a Medical or Safety Department
• Experience with audits and CAPA management
• Experience in business development activities
• Understanding of financial project management
• Strong communication and presentation skills
• Proficiency with electronic data systems and MS Office

Desirable

• GMC Registration with License to Practice
• Post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine
• Pharmacovigilance experience
• Experience in CRO, biotech, or pharmaceutical sectors

About Us

Simbec-Orion is a responsive, full-service CRO delivering studies from first-in-man to Phase III. We leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials, providing full-service clinical development solutions for small and mid-size drug developers. Our structure allows us to tailor and scale solutions to meet client needs, with the shared goal of improving patients’ lives.