Requirements: English
Company: Panda International
Region: Mechelen , Flanders
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 IIIII 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