Medical Director – Nephrology/Internal Medicine

This is a fully remote position, open to applicants in Italy, +11 more countries.

📋 Description

• Offer medical support and guidance for clinical trials and safety assessments within the client environment.

• Provide medical leadership to study teams.

• Develop clinical trial protocols based on the latest scientific data.

• Participate in site selection and review, as well as approve study protocols, amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents.

• Perform real-time medical monitoring of clinical studies.

• Guarantee the medical validity of primary endpoints and the safety of subjects.

• Early identification of medical issues and addressing customer concerns and corrective actions in collaboration with the Global Medical Indication Lead.

• Advise internal teams on procedural and budgetary matters, as well as protocol amendments.

• Coordinate internal functions to close gaps and resolve issues.

• Serve as a liaison between the sponsor and PPD internal departments throughout various study phases.

• Educate investigator sites through presentations and demonstrations of protocol-specific lab procedures.

• Oversee daily clinical trial activities, address issues, and respond to inquiries.

• Act 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.

• Provide medical training to site staff and CRA training in new indications.

• Ensure adherence to medical compliance with applicable SOPs and GCP.

• Collaborate with cross-functional study teams on medical risks, issues, and outcomes.

⛳️ Requirements

• Medical Doctor with a specialty in Nephrology or Internal Medicine.

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

• Required industry experience in clinical development.

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

• Proficient in spoken and written English.

• Proven understanding and experience with the NDA submission process.

• Familiarity with regulatory guidelines for adverse event reporting.

• Excellent communication and presentation skills.

• Strong team player.

• Knowledge and application of relevant SOPs and GCP.

🏝️ Benefits

• Resources necessary to achieve individual career aspirations.

• Appreciation for diverse experiences, backgrounds, and perspectives.

• EEO/Affirmative Action protections.

• Standard Monday–Friday work schedule.