Medical Director

Simbec-Orion; United Kingdom; On-site; GBP 90,000 - 140,000; Full time

Job summary

A leading company in clinical development is seeking a Medical Director to oversee the Medical Department, ensuring high standards in clinical trials. The role involves collaboration across departments, managing safety issues, and supporting business development activities. Ideal candidates will have a Medical Degree and significant experience in clinical research and leadership.

Qualifications

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

Responsibilities

• Lead and manage the Medical Department ensuring adherence to SOPs.
• Act as Medical Monitor for assigned trials.
• Participate in all stages of clinical trial development.

Skills

Leadership

Communication

Medical Monitoring

Safety Review

Business Development

Education

Medical Degree

Post-graduate qualification in Clinical Pharmacology or Pharmaceutical Medicine

Tools

MS Office

Electronic Data Capture Systems

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. In this role, you will lead and manage the Medical Department, ensuring that clinical trials are conducted with the highest standards of subject rights, safety, and data reliability. 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 adherence to SOPs and quality standards.
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 clinical trial development, including feasibility, protocol design, site selection, medical monitoring, AE/SAE management, and related meetings.
6. Respond to audit queries and ensure timely resolution.
7. Generate medical and patient narratives, safety update reports, and manage CAPAs and escalations.
8. Provide therapeutic area support, including internal training and review of study proposals.
9. Stay informed about trends and changes in medical management, regulations, and guidelines relevant to our projects.
10. Develop relationships with Key Opinion Leaders and investigators to gather insights and support business development.
11. Support pharmacovigilance activities, including review of safety reports and trend analysis.
12. Ensure clinical trials meet regulatory and ethical standards.
13. Assist in business development activities such as proposal requests and bid meetings.
14. Liaise with other functions to ensure client satisfaction and successful project execution.
15. Review and oversee the departmental budget.

Skills Required

Essential

• Medical Degree
• Experience in medical monitoring and safety review within clinical research
• Leadership experience in a Medical and/or Safety Department
• Experience with audits and CAPA management
• Business development experience, including proposal and bid support
• Understanding of project financial management
• Excellent communication and presentation skills
• Proficiency with electronic data capture 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 companies

About Us

Simbec-Orion is a full-service CRO delivering studies from first-in-human to Phase III. Our team leverages extensive therapeutic experience to execute a broad portfolio of trials. We are structured to provide tailored, scalable solutions for small and mid-size drug developers, led by a centralized leadership team.

Our focus is on adaptable delivery styles, communication, and operations to meet project demands, with the shared goal of improving patients’ lives.