Medical Director – Psychiatry

This is a fully remote position, open to applicants in Italy, +7 more countries.

📋 Description

• Lead medical initiatives for study teams, including the development of clinical trial protocols and the integration of the latest scientific insights.

• Assist in the selection of study sites.

• Evaluate and authorize study protocols, amendments, Clinical Study Reports, Informed Consent Forms, Case Report Forms, decisions on protocol deviations, and other clinical documentation.

• Conduct real-time medical oversight of clinical studies to ensure the validity of endpoints and the safety of participants.

• Proactively identify medical issues and address client concerns alongside the Global Medical Indication Lead.

• Advise internal teams and assist staff on procedural and budgetary matters as well as protocol modifications.

• Foster cross-functional commitment to bridge gaps and resolve issues promptly and effectively.

• Act as the primary liaison between the sponsor and PPD's internal departments throughout the various phases of the study.

• Provide educational presentations and demonstrations regarding protocol-specific lab procedures to investigator sites.

• Manage daily clinical trial activities to troubleshoot issues and respond to inquiries.

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

• Engage with investigators and address questions from IRB and Health Authorities.

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

• Offer medical training to site personnel and provide CRA training for new indications.

• Ensure adherence to relevant SOPs and GCP within the study.

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

⛳️ Requirements

• Medical Doctor.

• Board-certified in Psychiatry.

• Demonstrated clinical experience managing Psychiatry patients in a hospital setting.

• Required experience in clinical development within the industry.

• Substantial experience in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.

• Proficient in both spoken and written English.

• Proven understanding and experience with the NDA submission process.

• Familiarity with regulatory guidelines pertaining to adverse event reporting.

• Excellent communication and presentation abilities.

• Strong team player.

🏝️ Benefits

• Access to resources necessary for achieving personal career objectives.

• Valued diverse experiences, backgrounds, and perspectives.

• Commitment to equal employment opportunities and affirmative action employer.