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Director Medical Affairs
il y a 4 semaines
About the roleA fast-growing biopharmaceutical organization is expanding its Medical Affairs team and is looking for a Medical Lead for Belgium and Luxembourg. The company is known for its strong focus on biosimilars, biologics and innovative therapies, bringing high-quality and affordable treatments to patients across multiple therapeutic areas.In this role, you will lead the Medical Affairs function, provide strategic direction and ensure scientific and regulatory excellence. You will manage a team of Medical Advisors and MSLs, and oversee medical activities in key areas such as IBD, rheumatology, dermatology and allergy.Key ResponsibilitiesStrategic LeadershipDefine and execute the local medical strategy in alignment with global and regional objectives.Lead medical launch planning and lifecycle management activities.Represent Medical Affairs in cross-functional leadership teams and build trusted relationships with hospital pharmacists and buying groups.Team ManagementLead, mentor and develop a high-performing team of Medical Advisors and MSLs.Foster a culture of scientific excellence, compliance and collaboration.Provide oversight on supply chain planning from a medical perspective.Scientific & Medical OversightEnsure high-quality scientific exchange with external stakeholders.Oversee the medical review and approval of both promotional and non-promotional materials.Supervise Investigator-Initiated Trials, Phase 4 studies and real-world evidence programs.Governance & ComplianceEnsure compliance with SOPs, pharmacovigilance regulations, aRMM requirements and local legislation.Maintain oversight of medical documentation, reporting systems (e.g. Veeva) and training.Cross-functional CollaborationPartner closely with Market Access, Regulatory, Commercial and Pharmacovigilance teams.Contribute to brand planning, advisory boards and KOL engagement strategies.Budget & Resource ManagementManage the medical budget, including grants, consultancy fees and training.Allocate resources effectively and support strategic roadmap planning.Qualifications & SkillsAdvanced degree in Life Sciences (MD, PharmD or PhD preferred).Minimum 5–7 years of experience in Medical Affairs within pharma or biotech.Proven leadership experience and ability to manage cross-functional projects.Strong strategic mindset and business acumen.Experience designing and overseeing clinical trials, including IITs and Phase 4 studies.Strong background in data generation and real-world evidence initiatives.Solid publication track record in peer-reviewed journals.Excellent communication and interpersonal skills.Deep understanding of compliance, PV and regulatory frameworks.Ability to manage multiple priorities in a fast-paced environment.Proficiency with medical and CRM tools (e.g. Veeva, Salesforce).Fluency in English and either Dutch or French; trilingual capability is an asset.Strong knowledge of biosimilars, immunology and therapeutic areas such as IBD, rheumatology, dermatology and oncology is a plus.
