Medical Director - All European Countries

Job description

***Applications are welcome from all European Union countries, as we are pleased to consider candidates located across Europe.*** Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives. **Role Objectives:** The **Medical Director** at WEP Clinical serves as the primary medical and scientific expert for clinical trial protocols and Expanded Access Programs (EAPs), playing a crucial role in ensuring the accuracy, integrity, and successful execution of studies. As the protocol expert, the Medical Director is responsible for guiding investigators and internal/external teams in implementing and adhering to the study protocol. This includes but is not limited to medical and safety monitoring, data interpretation/presentation, and providing expert input on all medical aspects of the trial. As a Medical Director, you’ll collaborate with clinical, regulatory, and operational teams to ensure trials meet the highest ethical and scientific rigour standards. ### The Ideal Candidate: - Detail-oriented - Proactive - Collaborative - Strong Leader ### What You'll Do: - Serve as the primary medical point of contact for investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and addressing all medical inquiries. - Monitor clinical trials and Expanded Access Programs to ensure participant safety, data accuracy, protocol compliance, and timely resolution of medical issues. - Participate in investigator discussions during site selection to assess suitability and experience for the study or program. - Lead investigator calls to review inclusion/exclusion criteria and support optimal site selection and patient recruitment. - Act as the primary medical expert for the protocol, ensuring full understanding and adherence across investigators, study teams, and stakeholders. - Review and ensure proper documentation and timely reporting of AEs, SAEs, and other safety events. - Provide causality assessments for AEs, including those requiring expedited reporting to regulatory authorities. - Work with DSMBs and safety committees to provide safety oversight and evaluate ongoing trial data. - Deliver ongoing training and support to investigators, site staff, and internal/external teams on protocol requirements and the study’s medical/scientific objectives. - Participate in investigator meetings, site initiation visits, and study training to present protocol details, clarify eligibility criteria, and address medical concerns. - Lead the development of protocols, treatment guidelines, and project documents by providing key medical input on design, endpoints, criteria, and methodology. - Oversee protocol adherence, manage deviations, collaborate with cross-functional teams (clinical operations, regulatory, project management, pharmacovigilance), support safety reporting, and represent Medical Affairs in bid proposals, bid defences, client presentations, and cross-functional scientific discussions. ### What You'll Need: - A Medical Doctor (MD) degree is required - At least 5+ years of relevant clinical research experience, preferably medical monitoring - Ability to travel internationally and domestically up to 15% - Experience in EAP / CUP / NPP is preferred - Proven experience in protocol development, implementation, and interpretation - Experience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trials - In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes - Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint - Exceptional leadership, communication, and interpersonal skills to collaborate effectively with diverse teams and external stakeholders - Strong analytical and problem-solving abilities to make data-driven decisions and navigate complex challenges in the healthcare sector - Excellent interpersonal, communication, and organizational skills are required to work independently and in a team environment