Medical Director – Hematology/Oncology

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

📋 Description

• Oversees medical aspects of clinical trials to ensure adherence to company SOPs, client directives, good clinical practices, and regulatory standards.

• Participates in and presents at investigator and sponsor meetings, offering medical consultation to clients, investigators, and project team members, while also supporting business development efforts.

• Conducts medical review and analysis of clinical trial serious adverse events, marketed products ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR), as well as other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, and CSR).

• Ensures that pharmacovigilance tasks are carried out effectively.

• Complies with relevant regulations and ICH guidelines related to clinical trials, regulatory documents, and safety matters.

• Offers medical consultation to team members and addresses all study-related medical inquiries.

• Maintains clear communication with associates and clients, ensuring that all procedures are followed correctly.

• Provides therapeutic and protocol training on assigned studies, as needed.

• Conducts data reviews as specified in the client contract and data validation manual, including assessments of coding listings and/or comprehensive safety data to identify potential safety concerns.

• Aids in the writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., ensuring the accuracy and completeness of medical content.

• Participates in initiatives aimed at improving departmental processes.

• Monitors all safety variables (AE, laboratory abnormalities, alterations in patient medical status, evaluation of prescribed concomitant medications for protocol restrictions, and un-blinding requests) throughout clinical studies.

• Engages in discussions regarding medical concerns with principal investigators and clients that arise during a study, applying sound medical judgment in interpreting and making decisions regarding clinical situations related to the investigational study.

• Provides medical review of adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites.

• Oversees signal detection activities, scientifically reviews aggregate reports, contributes to label updates, and supports dossier maintenance and risk management efforts.

⛳️ Requirements

• MD required with a specialization in Oncology or Hemato-Oncology (active medical license preferred).

• Clinical experience in treating patients relevant to the applicant's training (approximately 2 years).

• Relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (around 1-2 years) in the industry; or direct experience in safety/Pharmacovigilance (approximately 2 years).

• Therapeutic expertise in one or more medical specialties or sub-specialties, including Oncology or Hemato-Oncology.

• Exceptional interpersonal skills, with strong influencing and team-building capabilities.

• Knowledge of guidelines (FDA, ICH, EMA, and GCP).

• Familiarity with biostatistics, data management, and clinical operations procedures.

• Ability to mentor and train other staff within pharmacovigilance.

• Strong decision-making, problem-solving, organizational, and analytical skills.

• Excellent oral and written communication abilities.

• Proficient in relevant safety databases (e.g., MedDRA).

• Willingness to travel domestically and internationally for short durations.

• Capacity to work independently, analyze tasks with attention to detail, and process sensitive complex information effectively.

• Proficient in computer productivity applications (e.g., word processors, spreadsheets, and presentations) required.

• Fluent in both spoken and written English.

• Capable of multitasking and possessing strong organizational skills.

🏝️ Benefits

• Health insurance.

• 401(k) matching.