Senior Director Medical Affairs

An international biopharmaceutical company is seeking an experienced Interim Senior Medical Director to provide medical leadership and oversight across clinical trials from Phase I to Phase III, with a focus on data integrity, patient safety, and regulatory compliance. Based in Europe, this strategic and hands-on role is ideal for a senior physician with deep experience in clinical research, preferably within immunology or SLE.

Key Details:

• Start Date: ASAP
• Contract Duration: 6 months
• Location: Leiden / Mechelen (Remote/Hybrid)
• Languages: Native-level English required
• Commitment: Full-time preferred
• Interview Process: Streamlined for quick onboarding

Responsibilities

• Clinical Study Leadership – Act as the medical representative of the Clinical Study Team (CST), overseeing all medical aspects of clinical trials.
• Medical Oversight – Monitor patient safety and data integrity, following ICH-GCP and internal standards as outlined in the Medical Monitoring and Oversight Plan.
• Medical Review & Input –
• Review patient data, CRFs, data listings, and study documents (protocols, SAPs, ICFs, IBs, IMPDs).
• Provide medical input on CRO/vendor selection, and work closely with CROs and key opinion leaders.
• Training & Support – Provide training to investigators, CRAs, and vendors, and act as a central point of contact for medical study-related questions.
• Risk Management & CAPA – Participate in the Safety Management Team, assess and mitigate safety risks, and contribute to CAPA development and protocol deviation management.
• Regulatory Contributions – Support regulatory submissions and external communication of results, including CSR review and publications.

Requirements

• MD or MD/PhD with at least 10 years’ experience in clinical research within the pharmaceutical industry.
• Minimum 3 years of medical practice experience; strong foundation in clinical medicine.
• Solid understanding of Phase II–III drug development, preferably in Immunology or SLE.
• Demonstrated leadership in matrixed clinical development teams.
• High-level strategic thinking and analytical capabilities.
• Experience collaborating with regulatory authorities, CROs, and internal R&D functions.
• Excellent scientific writing, communication, and presentation skills.
• Fluent/native-level English (spoken and written).

Why This Role?

• Leadership in High-Impact Trials – Guide the clinical strategy and execution of pivotal trials across therapeutic areas.
• Regulatory Influence – Shape key documents for regulatory submissions and external scientific communication.
• Strategic & Operational Blend – Combine high-level medical strategy with detailed trial oversight.
• Collaborative Environment – Work with cross-functional teams and top-tier CROs and KOLs.

Interview Process

• 1st Interview – With Clinical Development Leadership
• 2nd Interview – With Medical Affairs, Regulatory, or Program Team
• Start Date: ASAP