Requirements: English
Company: Panda International
Region: Mechelen , Flanders
An international biopharmaceutical company is seekingan experienced Interim Senior Medical Director to provide medicalleadership and oversight across clinical trials from Phase I toPhase III, with a focus on data integrity, patient safety, andregulatory compliance. Based in Europe, this strategic and hands-onrole is ideal for a senior physician with deep experience inclinical research, preferably within immunology or SLE. KeyDetails: - Start Date: ASAP - Contract Duration: 6 months -Location: EU-based (Remote/Hybrid) - Languages: Native-levelEnglish required - Commitment: Full-time preferred - InterviewProcess: Streamlined for quick onboarding Responsibilities -Clinical Study Leadership Act as the medical representative ofthe Clinical Study Team (CST), overseeing all medical aspects ofclinical trials. - Medical Oversight Monitor patient safety anddata integrity, following ICH-GCP and internal standards asoutlined in the Medical Monitoring and Oversight Plan. - MedicalReview & Input - Review patient data, CRFs, data listings,and study documents (protocols, SAPs, ICFs, IBs, IMPDs). - Providemedical input on CRO/vendor selection, and work closely with CROsand key opinion leaders. - Training & Support Providetraining to investigators, CRAs, and vendors, and act as a centralpoint of contact for medical study-related questions. - RiskManagement & CAPA Participate in the Safety Management Team,assess and mitigate safety risks, and contribute to CAPAdevelopment and protocol deviation management. - RegulatoryContributions Support regulatory submissions and externalcommunication of results, including CSR review and publications.Requirements - MD or MD/PhD with at least 10 years experience inclinical research within the pharmaceutical industry. - Minimum 3years of medical practice experience; strong foundation in clinicalmedicine. - Solid understanding of Phase IIIII drug development,preferably in Immunology or SLE. - Demonstrated leadership inmatrixed clinical development teams. - High-level strategicthinking and analytical capabilities. - Experience collaboratingwith regulatory authorities, CROs, and internal R&D functions.- Excellent scientific writing, communication, and presentationskills. - Fluent/native-level English (spoken and written). WhyThis Role? - Leadership in High-Impact Trials Guide the clinicalstrategy and execution of pivotal trials across therapeutic areas.- Regulatory Influence Shape key documents for regulatorysubmissions and external scientific communication. - Strategic& Operational Blend Combine high-level medical strategy withdetailed trial oversight. - Collaborative Environment Work withcross-functional teams and top-tier CROs and KOLs. InterviewProcess - 1st Interview With Clinical Development Leadership -2nd Interview With Medical Affairs, Regulatory, or Program Team -Start Date: ASAP #J-18808-Ljbffr