Requirements: English
Company: Galapagos
Region: Mechelen , Flanders
Pleased to meet you, we areGalapagos, a biotechnologycompany with operations in Europe and the U.S. dedicated todeveloping transformational medicines for more years of life andquality of life. We are in the business of changing lives. Focusingon high unmet medical needs, we synergize compelling science,technology, and collaborative approaches to create a deep pipelineof best-in-class small molecules, CAR-T therapies and biologics inoncology and immunology. With capabilities from lab to patient,including a decentralized CAR-T manufacturing network, we arecommitted to challenging the status quo and delivering results forour patients, employees and shareholders. We are looking for aSr.Medical Director Contractor to join our team for a period of 6months. Project Scope Physician providing medical expertise toensure timely planning, designing, conduct, monitoring, andreporting of clinical trials at Galapagos. Your mission - MedicalLeader Function representative of the CST - Responsible physicianfor all medical aspects of clinical studies from Phase 1 to Phase 3- Contribute to trial oversight by monitoring safety of trialsparticipants and integrity of trials data as documented in theMedical Monitoring and Oversight Plan - Evaluation of individualpatients with the aim of ascertaining the safety and wellbeing ofindividual patients in ongoing studies, following standard medicalpractice guidelines and competencies, like ICH/GCP, WHOdeclaration, and CanMED. - Actively contribute to the review ofstudy related listings and reconciliation - Provide medical inputin CRO/other vendors selection for the assigned clinical study -Interact with medical counterparts at CRO/key opinion leaders -Review of CRF and data management plan - Contribute to thepreparation of regulatory documents for CTA submission to CompetentAuthority and Ethics Committee/IRB including Briefing documents,IB, IMPD, and clinical study protocols, and ICFs - Contribute towriting/review of site guidelines, laboratory manuals, otherclinical study documents - Provide training of CRAs, investigators,other trial personnel, and act as central point of contact forstudy-related medical questions in collaboration with selectedvendors - Contribute to identification and mitigation of safetyrisks as member of the safety management team - Contribute todefine, review and approve protocol deviations - Contribute todefinition and execution of CAPAs - Actively contribute to thegeneration of the study results and review /approve SAP, mock TLFs,and CSR - Participate to external communications/publications ofthe clinical study results Who are you? - MD or MD/PhD with atleast 10 years experience in the pharmaceutical industry inclinical research as a medical director role (relevant clinicaland/or pharmaceutical industry experience in Immunology / SLE is aplus) - Ability to lead by influence in a matrix organisation - Hasa strong scientific foundation and analytical skills withpreferably work or post-doctoral training experience in an academicinstitution - A working knowledge of Phase II III drugdevelopment - Strong leadership skills and a strategic thinker -Energetic with a can-do attitude - Medical practice experience forminimum 3 years - Native-level English speaking and writing skillsare required What''s in it for you?At Galapagos, we are committed tobuilding meaningful partnerships with our consultants, offering acollaborative and supportive environment where you are recognizedas an integral part of the team. As a consultant, you will engagein a variety of projects, enabling you to expand your expertiseacross multiple domains. Our aim is to support your professionalgrowth while fostering a dynamic workplace that values and empowersyou as an equal partner. To streamline our hiring process, wekindly request that only individual freelancers and our preferredvendors submit CVs directly to us. Applications sent bynon-preferred agencies, recruitment firms, or other third partieson behalf of freelancers will not be considered. This approachhelps us maintain an efficient and direct connection with toptalent, ensuring a smooth experience for all involved.#J-18808-Ljbffr