Medical Director
W
WEP ClinicalClinical research
Remote, EU; Remote, Ireland. Applications are welcome from all European Union countries.Full-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 5+ years of relevant clinical research experience, preferably medical monitoring
- Required Skills
- Microsoft Excel
Requirements
- Hold a Medical Doctor (MD) degree.
- Have at least 5+ years of relevant clinical research experience; medical monitoring experience is preferred.
- Have experience in protocol development, implementation, and interpretation.
- Have experience in safety monitoring, adverse event reporting, and medical data review in clinical trials.
- Have in-depth knowledge of clinical trial design, regulatory requirements, and drug development processes.
- Be proficient with Microsoft Office, particularly Excel, Word, and PowerPoint.
- Be able to travel internationally and domestically up to 15%.
- Experience in EAP, CUP, or NPP is preferred.
- Bring leadership, communication, and interpersonal skills to collaborate with diverse teams and external stakeholders.
- Have analytical and problem-solving abilities and organizational skills to work independently and in a team environment.
Responsibilities
- Serve as the primary medical point of contact for investigators, regulatory agencies, and internal and external teams, providing consistent protocol interpretation and addressing medical inquiries.
- Monitor clinical trials and Expanded Access Programs for participant safety, data accuracy, protocol compliance, and timely resolution of medical issues.
- Participate in investigator discussions during site selection and lead calls reviewing inclusion and exclusion criteria.
- Act as the primary medical expert for the protocol and support understanding and adherence across investigators, study teams, and stakeholders.
- Review documentation and reporting of adverse events, serious adverse events, and other safety events, and provide causality assessments.
- Work with Data Monitoring and Safety Boards and safety committees to provide safety oversight and evaluate ongoing trial data.
- Train and support investigators, site staff, and internal and external teams on protocol requirements and study medical and scientific objectives.
- Participate in investigator meetings, site initiation visits, and study training to present protocol details and address medical concerns.
- Lead development of protocols, treatment guidelines, and project documents, providing medical input on design, endpoints, criteria, and methodology.
- Oversee protocol adherence, manage deviations, collaborate with clinical operations, regulatory, project management, and pharmacovigilance teams, and represent Medical Affairs in proposals and client and scientific discussions.
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