Medical Director – Oncology

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

📋 Description

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

• Act as the primary medical monitor for designated studies and the first point of contact for study sites.

• Address site inquiries related to eligibility and enrollment.

• Conduct safety monitoring and manage patient care.

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

• Collaborate cross-functionally with sponsors to define, plan, and deliver medical monitoring.

• Develop and offer medical expertise for Medical Monitoring Plans and Safety Management Plans.

• Review protocols and associated training materials.

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

• Attend and engage in Investigator Meetings as necessary.

• Provide consultation on deviations from inclusion/exclusion criteria, subject eligibility, and protocol-related inquiries.

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

• Offer emergency medical advice via telephone and email outside of regular business hours.

• 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 concerns, adverse events, and trends or signals related to safety, and formulate appropriate responses.

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

• Advise the Pharmacovigilance/Drug Safety team on the assessment and reporting of serious adverse events (SAEs).

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

• Assist with the medical review of MedDRA-coded adverse events and medical histories, as well as WHODrug-coded concomitant medications or therapies.

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

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

⛳️ Requirements

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

• Strong foundation in clinical medicine.

• Practical experience in medical research or clinical development.

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

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

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

• Expertise in Phase I–IV studies.

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

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

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

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

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

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

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

• Customer- and quality-focused.

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

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

🏝️ Benefits

• Equal opportunity employment.

• Reasonable accommodations for candidates with disabilities during recruitment and selection upon request.