Sr. Medical Director - Mechelen (BE), Consultant (6 months contract)

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

We are looking for a Sr. Medical Director Contractor to join our team for a period of 6 months.

Project Scope

Physician providing medical expertise to ensure timely planning, designing, conduct, monitoring, and reporting of clinical trials at Galapagos.

Your mission

• Medical Leader Function representative of the CST

• Responsible physician for all medical aspects of clinical studies from Phase 1 to Phase 3

• Contribute to trial oversight by monitoring safety of trial’s participants and integrity of trial’s data as documented in the Medical Monitoring and Oversight Plan

  • Evaluation of individual patients with the aim of ascertaining the safety and wellbeing of individual patients in ongoing studies, following standard medical practice guidelines and competencies, like ICH/GCP, WHO declaration, and CanMED.

• Actively contribute to the review of study related listings and reconciliation

• Provide medical input in 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 the preparation of regulatory documents for CTA submission to Competent Authority and Ethics Committee/IRB including Briefing documents, IB, IMPD, and clinical study protocols, and ICFs

• Contribute to writing/review of site guidelines, laboratory manuals, other clinical study documents

• Provide training of CRAs, investigators, other trial personnel, and act as central point of contact for study-related medical questions in collaboration with selected vendors

• Contribute to identification and mitigation of safety risks as member of the safety management team

• Contribute to define, review and approve protocol deviations

• Contribute to definition and execution of CAPAs

• Actively contribute to the generation of the study results and review /approve SAP, mock TLFs, and CSR

• Participate to external communications/publications of the clinical study results

Who are you?

• MD or MD/PhD with at least 10 years experience in the pharmaceutical industry in clinical research as a medical director role (relevant clinical and/or pharmaceutical industry experience in Immunology / SLE is a plus)

• Ability to lead by influence in a matrix organisation

• Has a strong scientific foundation and analytical skills with preferably work or post-doctoral training experience in an academic institution

• A working knowledge of Phase II – III drug development

• Strong leadership skills and a strategic thinker

• Energetic with a can-do attitude

• Medical practice experience for minimum 3 years

• Native-level English speaking and writing skills are required

What's in it for you? 

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.

To streamline our hiring process, we kindly request that only individual freelancers and our preferred vendors submit CVs directly to us. Applications sent by non-preferred agencies, recruitment firms, or other third parties on behalf of freelancers will not be considered. This approach helps us maintain an efficient and direct connection with top talent, ensuring a smooth experience for all involved.