Medical Director

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Act as the main medical liaison for investigators, regulatory bodies, and both internal and external teams.

• Ensure uniform interpretation of protocols and respond to medical inquiries.

• Supervise clinical trials and Expanded Access Programs to ensure participant safety, data integrity, compliance with protocols, and swift resolution of medical issues.

• Engage in discussions with investigators during the site selection process.

• Facilitate investigator calls to discuss inclusion/exclusion criteria and assist in site selection and patient recruitment.

• Serve as the principal medical expert for the protocol, ensuring all stakeholders adhere to it.

• Review documentation and guarantee timely reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety occurrences.

• Provide assessments of causality for adverse events, particularly those needing expedited regulatory reporting.

• Collaborate with Data Safety Monitoring Boards (DSMBs) and safety committees to oversee safety and evaluate ongoing trial data.

• Offer training and support to investigators, site personnel, and both internal and external teams.

• Participate in investigator meetings, site initiation visits, and study training sessions.

• Lead the creation of protocols, treatment guidelines, and project documents, contributing medical insights on design, endpoints, criteria, and methodologies.

• Ensure adherence to protocols and manage any deviations.

• Work alongside clinical operations, regulatory affairs, project management, and pharmacovigilance teams.

• Assist in safety reporting and represent Medical Affairs in bids, defense presentations, client meetings, and cross-functional scientific discussions.

⛳️ Requirements

• A Medical Doctor (MD) degree is mandatory.

• Minimum of 5+ years of relevant experience in clinical research, ideally in medical monitoring.

• Willingness to travel domestically and internationally up to 15% of the time.

• Experience in Expanded Access Programs (EAP), Compassionate Use Programs (CUP), or Named Patient Programs (NPP) is advantageous.

• Demonstrated experience in protocol development, execution, and interpretation.

• Knowledge in safety monitoring, adverse event reporting, and medical data analysis within clinical trial contexts.

• Extensive understanding of clinical trial design, regulatory requirements, and drug development processes.

• Proficient in Microsoft Office applications, especially Excel, Word, and PowerPoint.

• Outstanding leadership, communication, and interpersonal skills for effective collaboration with diverse teams and external stakeholders.

• Strong analytical and problem-solving skills for making data-driven decisions and addressing complex challenges in healthcare.

• Excellent interpersonal, communication, and organizational skills necessary for independent work and teamwork.

• Resume must be submitted in English.

🏝️ Benefits

• Group Private Medical Insurance.

• Group General Life Assurance.

• Group Critical Illness and Group Income Protection.

• Salary sacrifice pension scheme.

• Enhanced maternity & paternity pay.

• Educational Assistance allowance.

• Paid volunteering day.

• Wellness, growth, development, and team relationship initiatives.

• Team events.

• Inclusive and supportive work environment.

• Equal-opportunity employment with reasonable accommodations for qualified individuals with known disabilities.