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) - Therapeutic Focus:
Immunology / SLE (Systemic Lupus Erythematosus)
Interested?
Send your CV to
Khanyi Mabena
at
k.-
, or reach out directly at
to learn more.
Solliciteren