Medical Director – Oncology

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

📋 Description

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

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

• Address site inquiries regarding eligibility and enrollment; manage safety and patient care.

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

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

• Create and contribute medical insights to Medical Monitoring Plans and Safety Management Plans.

• Review protocols and the accompanying training materials.

• Educate project teams on the disease or therapeutic area, study design, and procedures.

• Attend and engage in Investigator Meetings as needed.

• Support decisions regarding inclusion/exclusion deviations and protocol-related inquiries.

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

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

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

• Review listings, laboratory reports, subject profiles, safety data, medical histories, concomitant medications, and patient-risk trends.

• Offer medical oversight to identify safety concerns and adverse events while developing appropriate responses.

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

• Advise Pharmacovigilance/Drug Safety on Serious Adverse Event (SAE) case evaluation and reporting.

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

• Assist with the medical review of MedDRA-coded adverse event and medical history terms and WHODrug-coded concomitant medications/therapies.

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

• Ensure adherence to company Standard Operating Procedures and clinical-trial safety medical-monitoring practices.

⛳️ Requirements

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

• A solid foundation in clinical medicine, with hands-on experience in medical research or clinical development.

• A minimum of 10-15 years of experience in clinical development, with a strong background in medical monitoring, clinical trial oversight, and pharmacovigilance.

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

• Proficiency in Phase I-IV studies.

• Extensive knowledge of regulatory requirements, including FDA and EMA, as well as ICH-GCP guidelines.

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

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

• Capacity to maintain confidentiality and handle sensitive medical and client data responsibly.

• Strong leadership, organizational, communication, interpersonal, teamwork, and collaboration capabilities.

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

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

• Additional certifications or training in specific therapeutic areas may be beneficial.

🏝️ Benefits

• Commitment to equal opportunity.

• Accommodations for candidates with disabilities available upon request.