Medical Director – Oncology

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

📋 Description

• Deliver medical and scientific support to clinical research initiatives, study teams, and investigators.

• Provide medical supervision for clinical trials as the Medical Monitor on behalf of sponsor organizations.

• Act as the primary liaison for sponsor medical teams and serve as the first-line medical resource for project teams.

• Address inquiries from site coordinators and investigators regarding protocol criteria, clarifications, and compliance matters, including 24/7 on-call availability.

• Evaluate clinical research proposals, data, protocols, training materials, informed consent documents, Investigator Drug Brochures, eCRFs, analysis plans, clinical study reports, regulatory submissions, and safety reports.

• Ensure that medical activities adhere to GCP standards and operate effectively.

• Engage with clients, key opinion leaders, investigators, site personnel, sponsor representatives, and FDA officials concerning drug development and study-related issues.

• Review and contribute to the development of protocols, study endpoints, inclusion/exclusion criteria, investigator selection, recruitment, retention, training, and investigator meetings.

• Create medical monitoring plans and provide protocol query and site support coverage.

• Assess SAE reports and narratives, monitor safety queries, evaluate study safety profiles, and review IND/SUSAR reports and Investigator Brochures.

• Analyze eCRFs, data analysis plans, safety fields, medical coding, data tables, listings, figures, and clinical study reports.

• Assist with DSMB/adjudication committee activities as needed.

• Support business development, proposal generation, marketing presentations, sales pitches, and feasibility discussions.

• Conduct literature reviews, develop training sessions, interpret clinical data, draft procedures, and engage in quality improvement initiatives.

• Carry out other related responsibilities as assigned by the Chief Medical Officer.

⛳️ Requirements

• Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.

• A minimum of 10 years of experience is required, encompassing medical practice, academia, clinical research, or drug development.

• Preferred experience of 3–5 years in the biopharmaceutical industry, which may be included in the 10-year experience.

• Board Certified or Board Eligible in Oncology is mandatory; Oncology/Hematology experience is required.

• A background in Urology/Surgical Oncology is preferred.

• Capability to collaborate with multidisciplinary colleagues and translate concepts into actionable strategies.

• Ability to work autonomously with minimal supervision and effectively within team and matrix settings.

• Strong organizational skills to manage multiple projects with changing priorities efficiently.

• Exceptional oral, written, and interpersonal communication abilities.

🏝️ Benefits

• Potential incentive plans, bonuses, and/or other forms of compensation may be available.

• Health and welfare benefits may be provided.