Medical Director – Oncology

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

📋 Description

• Collaborate with business development and internal stakeholders to critically evaluate protocols, suggest study designs, and create endpoints.

• Act as the primary medical monitor and the initial point of contact for study sites.

• Address inquiries from sites regarding eligibility and enrollment.

• Conduct safety assessments and manage patient care.

• Provide guidance on medical inquiries and issues that arise during clinical trials.

• Define, strategize, and deliver medical monitoring for assigned clinical trials alongside cross-functional teams and sponsors.

• Create Medical Monitoring Plans and Safety Management Plans.

• Review protocols and training materials related to the protocols.

• Educate project teams on disease areas, study design, and operational procedures.

• Attend and engage in Investigator Meetings when applicable.

• Consult on deviations from inclusion/exclusion criteria and other protocol-related inquiries.

• Respond to medical inquiries from Investigators, Ethics Committees, and Data Monitoring Committees.

• Provide emergency medical guidance outside of standard business hours via phone and email.

• Document protocol inquiries and their responses in the centralized tracker/CTMS.

• Review listings, laboratory reports, subject profiles, safety data, serious adverse events, medical histories, and concomitant medications.

• Identify safety issues, adverse events, risks, trends, and safety signals, and formulate appropriate responses.

• Consult on abnormal laboratory values regarding their clinical and protocol significance.

• Advise Pharmacovigilance/Drug Safety on the assessment and reporting of Serious Adverse Events (SAE).

• Review subject narratives, periodic and interim safety reports, and other relevant study documentation.

• Assist with the medical review of MedDRA- and WHODrug-coded terms.

• Review Statistical Analysis Plans, tables, figures, listings, and Clinical Study Reports as necessary.

• Ensure adherence to company Standard Operating Procedures and best practices in clinical trial safety monitoring.

⛳️ Requirements

• Doctor of Medicine (MD) from a recognized institution.

• Robust foundation in clinical medicine.

• Practical experience in medical research or clinical development.

• Minimum of 10-15 years of experience in clinical development.

• Strong background in medical monitoring, clinical trial oversight, and pharmacovigilance.

• Advanced certification, specialization, or expertise in a therapeutic area such as hematology or oncology is highly desirable.

• Proven experience managing clinical trials within a Contract Research Organization or pharmaceutical company.

• Proficiency in Phase I-IV studies.

• Comprehensive knowledge of FDA, EMA, and ICH-GCP guidelines.

• Strong leadership, organizational, and communication abilities.

• Capacity to work collaboratively in cross-functional teams and effectively engage with internal and external stakeholders.

• Expertise in reviewing medical data, safety oversight, and risk management in clinical trials.

• Ability to make informed decisions based on clinical data analysis.

• Commitment to maintaining confidentiality and managing sensitive medical and client information responsibly.

• Experience working with global clinical trials and multi-regional study teams.

• Excellent interpersonal and teamwork abilities.

• Detail-oriented, customer-focused, and quality-driven.

🏝️ Benefits

• Flexible remote work arrangement.

• Commitment to equal opportunity employment.

• Recruitment and selection accommodations available for candidates with disabilities upon request.