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