Medical Director, Oncology

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

📋 Description

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

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

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

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

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

• Contribute medical insights to Medical Monitoring Plans and Safety Management Plans.

• Review protocols and training materials related to protocols.

• Educate project teams on disease or therapeutic areas, study designs, and associated procedures.

• Attend and engage in Investigator Meetings as applicable.

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

• Respond to medical questions 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 responses in the centralized tracker/CTMS.

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

• Identify safety issues and adverse events, developing and executing suitable responses.

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

• Advise Pharmacovigilance/Drug Safety regarding SAE assessment and reporting inquiries.

• 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 necessary.

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

⛳️ Requirements

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

• Strong basis in clinical medicine.

• Practical experience in medical research or clinical development.

• A minimum of 10–15 years’ experience in clinical development.

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

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

• Documented experience managing clinical trials in a CRO or pharmaceutical company setting.

• Expertise in Phase I–IV studies.

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

• Strong leadership, organizational, and communication abilities.

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

• Proficiency in medical data review, safety oversight, and clinical trial risk management.

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

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

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

• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.

🏝️ Benefits

• Equal opportunity and disability accommodations available upon request.

• Remote work arrangement.