Medical Director – Oncology

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

📋 Description

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

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

• Address site inquiries regarding eligibility and enrollment while managing safety and patient care.

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

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

• Create and review Medical Monitoring Plans, Safety Management Plans, protocols, and training materials.

• Educate project teams on disease areas, study design, and procedural protocols.

• Attend and participate in Investigator Meetings when applicable.

• Assist in making decisions regarding inclusion/exclusion deviations and protocol-related inquiries.

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

• Provide emergency medical guidance outside of normal business hours via telephone and email.

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

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

• Identify safety concerns and adverse events, developing and executing appropriate responses.

• Advise study teams on out-of-range laboratory values and their clinical or protocol significance.

• Counsel Pharmacovigilance/Drug Safety on SAE case assessments and reporting.

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

• Assist with MedDRA and WHODrug coding reviews.

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

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

⛳️ Requirements

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

• Strong background in clinical medicine, complemented by practical experience in medical research or clinical development.

• A minimum of 10–15 years of experience in clinical development, medical monitoring, clinical trial oversight, and pharmacovigilance.

• Demonstrated experience managing Phase I–IV clinical trials within a Contract Research Organization or pharmaceutical company environment.

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

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

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

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

• Strong leadership, organizational, communication, interpersonal, and teamwork abilities.

• Capacity to work collaboratively with cross-functional teams and both internal and external stakeholders.

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

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

• Excellent customer- and quality-focused approach.

🏝️ Benefits

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

• Remote work arrangement.