Clinical Trial Physician – Phase I, EMEA

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

📋 Description

• Lead medical initiatives for study teams.

• Develop clinical trial protocols utilizing the most current scientific data.

• Assist in site selection and the review and approval of study protocols, amendments, clinical study reports (CSRs), informed consent forms (ICFs), case report forms (CRFs), protocol deviation decisions, and other clinical documentation.

• Conduct real-time medical monitoring of clinical trials.

• Validate the medical integrity of primary endpoints and ensure the safety of study participants.

• Proactively identify and address medical issues in collaboration with the Global Medical Indication Lead.

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

• Serve as the medical liaison for both internal and external stakeholders.

• Engage with investigators and respond to inquiries from Institutional Review Boards (IRBs) and Health Authorities.

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

• Provide medical training to site personnel and conduct Clinical Research Associate (CRA) training on new indications.

• Ensure adherence to the medical components of studies by implementing applicable Standard Operating Procedures (SOPs) and Good Clinical Practices (GCP).

• Collaborate with cross-functional study team members to clarify medical risks, concerns, and outcomes.

• Standardize responses, eligibility criteria, and protocol deviation decisions when multiple physicians are involved in a protocol.

⛳️ Requirements

• Medical Doctor (MD).

• Preferred specialty education in areas such as neurology, hematology, dermatology, immunology, rheumatology, internal medicine, or pediatrics.

• Prior experience in the industry is preferred.

• Proficient in English, both written and verbal.

• Willingness to travel.

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

• Proactive approach to problem-solving and negotiation.

• Strong communication abilities for effective collaboration in a cross-functional, matrix environment.

• Knowledgeable in and able to apply relevant SOPs and GCP.

• Capability to exercise judgment and escalate issues promptly as required.

🏝️ Benefits

• A healthy and balanced work environment.

• Opportunities for collaboration and professional growth.

• Travel opportunities.