Medical Director

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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 to protect subjects' rights, safety, and wellbeing, and that the data collected is reliable. You will hold 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, technical writing) to promote best practices across the organization.

Key Accountabilities

Lead and manage the Medical Department, ensuring quality and adherence to SOPs.

Serve as the point of contact for internal and external stakeholders regarding medical and safety issues.

Review and update departmental SOPs regularly to comply with current regulations and guidelines.

Act as Medical Monitor for assigned trials.

Participate in all stages of clinical trial development, including feasibility, protocol design, site selection, medical monitoring, and safety management.

Respond to audit queries and ensure audit readiness.

Generate medical and patient narratives, safety update reports, and manage CAPAs and escalations.

Provide therapeutic area support and internal training, review proposals, and support business development.

Stay informed about trends and changes in medical management, regulations, and guidelines.

Develop relationships with Key Opinion Leaders and investigators.

Support pharmacovigilance activities, including safety data review and reporting.

Ensure clinical trials meet all regulatory and ethical standards.

Assist in business development activities, including proposals and bid defenses.

Liaise with other functions to ensure client satisfaction.

Review departmental budgets and oversee financial management.

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

Business development experience, including proposals and strategic advice

Understanding of project management and departmental budgeting

Excellent 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 industries

About Us
Simbec-Orion is a full-service CRO offering comprehensive clinical development solutions. We focus on scalable, tailor-made approaches to help clients achieve their clinical and commercial objectives, aiming to improve patients’ lives.

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