Medical Director

Simbec-Orion; United Kingdom; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading company in clinical development seeks a Medical Director to oversee the Medical Department. This role involves leading clinical trials, ensuring compliance with regulations, and working with various departments to maintain high standards for patient safety and data integrity. Join a dynamic team dedicated to advancing medicine.

Qualifications

• Proven leadership experience in clinical development.
• Strong understanding of clinical trial regulations and processes.
• Experience in managing medical departments.

Responsibilities

• Lead and manage the Medical Department ensuring compliance and quality.
• Play a key role in all stages of Clinical Trial Development.
• Collaborate with stakeholders and ensure patient safety.

Skills

Leadership

Medical Knowledge

Regulatory Compliance

Collaboration

Data Interpretation

Education

Medical Degree

Relevant Medical Training

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, where you will lead and manage the Medical Department, ensuring that Clinical Trials are conducted with subjects' rights, safety, and wellbeing protected, and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical Studies conducted by Simbec–Orion and will provide interpretation of clinical data.

You will work collaboratively with cross-departmental medical monitoring activities (e.g., clinical operations; project management; pharmacovigilance; business development; biometrics; regulatory and technical writing) to drive best practices across the organization.

Key Accountabilities

1. Leads and manages the Medical Department, reviewing the department's quality of medical tasks and ensuring SOP compliance.
2. Serves as the point of contact for internal and external stakeholders for issue escalation related to medical and safety issues in the study.
3. Ensures departmental SOPs are regularly reviewed to comply with current regulations and guidelines.
4. Acts as Medical Monitor for assigned trials.
5. Participates in all stages of Clinical Trial Development, including feasibility assessments, protocol design, site selection, medical monitoring plan development, ongoing medical support, and management of adverse events.
6. Responds to audit queries.
7. Generates Medical and Patient narratives and safety update reports.
8. Addresses departmental CAPAs, escalations, and communicates audit findings during monthly meetings.
9. Provides therapeutic area support and internal training, reviews study proposals.
10. Maintains knowledge of trends and regulatory changes relevant to the company's projects.
11. Develops relationships with Key Opinion Leaders and investigators for ongoing studies and business development.
12. Supports Pharmacovigilance in safety data review and trend analysis.
13. Ensures clinical trials meet regulatory and ethical standards.
14. Contributes to business development activities, including proposals and bid meetings.
15. Coordinates with other functions to ensure client satisfaction.
16. Reviews and oversees the departmental budget.