Medical Director, Oncology

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

📋 Description

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

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

• Address site inquiries related to eligibility and enrollment, while managing safety and patient care.

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

• Define, plan, and deliver medical monitoring in conjunction with cross-functional teams and sponsors.

• Create Medical Monitoring Plans and Safety Management Plans.

• Review protocols and training materials associated with protocols.

• Educate project teams on disease or therapeutic areas, study design, and processes.

• Attend and engage in Investigator Meetings as necessary.

• Aid in decisions related to inclusion/exclusion deviations and protocol-associated inquiries.

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

• Offer emergency medical guidance outside of regular business hours via phone and email.

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

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

• Evaluate patient risk and identify safety trends or signals.

• Consult on out-of-range laboratory values for their clinical and protocol relevance.

• Advise Pharmacovigilance/Drug Safety on the evaluation and reporting of SAE cases.

• Review subject narratives, periodic and interim safety reports, and 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 required.

• Ensure adherence to company SOPs and clinical trial safety medical monitoring practices.

⛳️ Requirements

• Doctor of Medicine (MD) degree from an accredited institution.

• Solid foundation in clinical medicine.

• Practical experience in medical research or clinical development.

• Minimum of 10–15 years of experience in clinical development, with significant expertise in medical monitoring, clinical trial management, and pharmacovigilance.

• Demonstrated experience in managing clinical trials within a Contract Research Organization or pharmaceutical company setting.

• Proficient in Phase I–IV studies.

• Comprehensive understanding of regulatory requirements, including FDA and EMA guidelines, as well as ICH-GCP standards.

• Advanced certification, specialization, or therapeutic-area expertise in hematology, oncology, or another pertinent medical field is highly preferred.

• Strong leadership, organizational, and communication abilities.

• Capability to collaborate in cross-functional teams and interact effectively with both internal and external stakeholders.

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

• Exceptional attention to detail and the ability to make informed decisions based on clinical data.

• Capacity to maintain confidentiality and manage sensitive medical and client information responsibly.

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

• Excellent interpersonal and teamwork skills; detail-oriented, with a focus on customer satisfaction and quality.

🏝️ Benefits

• Equal opportunity and accommodations available for candidates with disabilities upon request.