Medical Director (Oncology) - Clinical Trials

About the role

Everest, a full-service CRO founded in 2004 and headquartered in Toronto with offices across North America, Asia and Europe, is looking for a Medical Director (Oncology) to join its team in Serbia. The role centres on medical monitoring of clinical trials, protocol review and safety oversight.

Key responsibilities

• Work with business development and internal stakeholders on protocol appraisal, study design and endpoints
• Act as primary medical monitor for assigned studies, being the first point of contact with sites on eligibility and enrollment, and handling safety and patient management
• Define, plan and deliver medical monitoring with sponsors, and contribute to Medical Monitoring Plans and Safety Management Plans
• Review protocols and training materials, train the project team, and take part in investigator meetings where applicable
• Advise on inclusion/exclusion criteria deviations and respond to queries from investigators, ethics committees and data monitoring committees
• Provide emergency medical guidance by phone and email outside normal hours, documenting all answers in the CTMS
• Review listings, lab reports and subject profiles, and oversee safety data including SAEs, lab data, medical history and concomitant medications
• Advise the Pharmacovigilance/Drug Safety team on SAE case assessment and reporting, and review safety reports and subject narratives
• Assist with MedDRA coding of AEs and WHODrug coding of concomitant medications, and review statistical analysis plans, tables, figures, listings and CSRs
• Ensure compliance with SOPs for clinical trial safety medical monitoring

Required profile

• MD from an accredited institution, or equivalent medical degree
• At least 10-15 years of experience in clinical development, with a strong background in medical monitoring, clinical trial oversight and pharmacovigilance
• Proven experience managing clinical trials in a CRO or pharmaceutical company, with expertise in Phase I-IV studies
• Advanced certification or specialization in hematology, oncology or another relevant field is highly preferred
• Experience with global clinical trials and multi-regional study teams

Required skills

• In-depth knowledge of regulatory requirements (FDA, EMA) and ICH-GCP guidelines
• Expertise in medical data review, safety oversight and risk management in clinical trials
• Strong leadership, organizational and communication skills, and ability to work in cross-functional teams
• Attention to detail, confidentiality and customer- and quality focus