Senior Medical Director – Contractor (Immunology / SLE Focus)
Location
Mechelen, Belgium
Business Sector
Biotechnology
Contact email
Job ref
26099
Published
11 minutes ago
Senior Medical Director – Contractor (Immunology / SLE Focus) Belgium or Remote (Europe-based) – 6-Month Contract
Job Description As Senior Medical Director (Contractor), you will play a key leadership role in the clinical development of small molecule programs, providing high-level medical and scientific expertise to ensure excellence in the planning, design, execution, monitoring, and reporting of clinical trials from Phase I through Phase III.
You will serve as the Medical Leader and Clinical Science Team (CST) representative, collaborating cross-functionally with internal teams, CROs, and external partners to drive clinical strategy and ensure patient safety, data integrity, and regulatory compliance.
This is a unique opportunity to contribute to life-changing therapies in immunology, particularly in Systemic Lupus Erythematosus (SLE)—within an innovative and dynamic environment.
Key Responsibilities:
Serve as the Medical Leader for assigned clinical programs and as the CST representative.
Act as the responsible physician for all medical aspects of clinical studies (Phase I–III).
Monitor patient safety and data integrity as outlined in the Medical Monitoring and Oversight Plan.
Evaluate individual patient data to ensure safety and well-being, following ICH/GCP and WHO/CanMED standards.
Review and reconcile study-related listings, case report forms (CRFs), and data management plans.
Provide medical input into CRO/vendor selection and maintain active collaboration with medical counterparts and KOLs.
Contribute to regulatory documentation including CTAs, IBs, IMPDs, protocols, ICFs, and briefing materials.
Develop and review study guidelines, lab manuals, and SOPs.
Deliver training for CRAs, investigators, and study personnel; act as the central medical contact for study-related inquiries.
Participate in safety management and contribute to risk mitigation and CAPA processes.
Support statistical analysis planning (SAP), mock TLFs, and Clinical Study Reports (CSRs).
Contribute to external publications and presentation of clinical study results.
Essential Requirements:
MD with a minimum of 10 years’ experience in clinical research and the pharmaceutical industry.
Proven track record as a Medical Director in Phase II–III clinical trials.
Strong clinical and/or industry experience in Immunology (SLE experience highly desirable).
Minimum 3 years of medical practice experience.
Deep scientific understanding and analytical mindset, ideally supported by post-doctoral or academic experience.
Ability to lead cross-functional teams and influence in a matrix organization.
Excellent communication and presentation skills, with native-level English fluency (written and spoken).
Energetic, strategic, and proactive mindset with strong leadership capabilities.
Additional Insights:
Start Date: ASAP
Contract Duration: 6 months (until March 2026)
Minimum Commitment: 80%
Location: Flexible within Europe (some travel to Belgium required every other week or monthly)