Requirements: English
Company: Panda International
Region: Mechelen , Flanders
1 day ago Be among the first 25 applicants Directmessage the job poster from Panda International Partner &Manager @ Panda International | Recruitment Advisor | Biopharma andMedtech An international biopharmaceutical company is seeking anexperienced 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. - StartDate: ASAP - Contract Duration: 6 months - Commitment: Full-timepreferred - Interview Process: Streamlined for quick onboardingResponsibilities - Clinical Study Leadership Act as the medicalrepresentative of the Clinical Study Team (CST), overseeing allmedical aspects of clinical trials. - Medical Oversight Monitorpatient safety and data integrity, following ICH-GCP and internalstandards as outlined in the Medical Monitoring and Oversight Plan.- Medical Review & Input - Review patient data, CRFs, datalistings, and study documents (protocols, SAPs, ICFs, IBs, IMPDs).- Provide medical input on CRO/vendor selection, and work closelywith CROs and key opinion leaders. - Training & Support Provide training to investigators, CRAs, and vendors, and act as acentral point of contact for medical study-related questions. -Risk Management & CAPA Participate in the Safety ManagementTeam, 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 Seniority level - Seniority level DirectorEmployment type - Employment type Temporary Job function - Jobfunction Science and Product Management Referrals increase yourchances of interviewing at Panda International by 2x Get notifiedabout new Director Medical Affairs jobs in Mechelen, FlemishRegion, Belgium. Medical Director, Oncology Diagnostics - EuropeAntwerp, Flemish Region, Belgium 2 days ago Brussels, BrusselsRegion, Belgium 1 month ago Senior Director of Medical Strategy(Endocrinology) Antwerp, Flemish Region, Belgium 1 day ago GlobalMedical Director Gastroenterology Specialty Care Brussels, BrusselsRegion, Belgium 2 weeks ago Sr. Medical Director - Mechelen (BE),Consultant (6 months contract) Mechelen, Flemish Region, Belgium 3days ago Medical Director -Oncology/Cardiology/Gastroenterology/Endocrinology/Radiology/InfectiousDisease/Immunology/Nephrology/Psychiatrist (Senior) MedicalDirector - Rheumatology (Client - dedicated), EMEA Brussels,Brussels Region, Belgium 1 week ago Biostatistics Director (m/f/x)for Evidence Generation Antwerp, Flemish Region, Belgium 3 days agoWere unlocking community knowledge in a new way. Experts addinsights directly into each article, started with the help of AI.#J-18808-Ljbffr