Clinical Trial Physician – Phase I, EMEA

This is a fully remote position, open to applicants in Belgium, +5 more countries.

📋 Description

• Offer medical leadership to research teams.

• Develop clinical trial protocols utilizing the latest scientific insights.

• Participate in site selection and evaluate and approve study protocols and amendments.

• Review Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions, and various clinical documents.

• Perform real-time medical monitoring of clinical trials.

• Ensure the medical validity of primary endpoints and the safety of study subjects.

• Identify, escalate, and resolve medical issues in collaboration with the Global Medical Indication Lead.

• Analyze clinical trial data for regulatory submissions, manuscripts, and other publications.

• Serve as the medical point of contact for both internal and external stakeholders.

• Engage with investigators and respond to inquiries from IRB and Health Authorities.

• Prepare and deliver presentations to study executives and independent safety committees when necessary.

• Provide medical training to site personnel and CRA training on new indications.

• Ensure compliance with medical aspects of the study by adhering to SOPs and GCP.

• Collaborate with cross-functional study team members on medical risks, challenges, and outcomes.

• Align responses from sites/IRB/RA, eligibility decisions, and protocol deviation decisions when multiple physicians are involved with a protocol.

⛳️ Requirements

• Medical Doctor degree.

• Preferred educational background in relevant specialties such as neurology, hematology, dermatology, immunology, rheumatology, internal medicine, or pediatrics.

• Prior experience in the industry is preferred.

• Excellent proficiency in English, both written and spoken.

• Willingness to travel.

• Demonstrated interpersonal skills to lead a study team and provide medical guidance and assessments.

• Proactive problem-solving and negotiation abilities.

• Awareness of diverse cultural needs in a global organization.

• Strong communication and teamwork skills.

• Capacity to collect decision-making information, negotiate, and convey decisions and actions.

• Knowledge and application of relevant SOPs and GCP.

🏝️ Benefits

• A healthy and balanced work environment.

• Opportunities for collaboration and development.

• Ability to be part of a global team.

• Meaningful work that contributes to life-changing therapies and improved health outcomes.