Senior Medical Director, Medical Monitor

This is a fully remote position, open to applicants in Philippines, +1 more country.

📋 Description

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

• Manages all medical components of contracted responsibilities throughout the pharmaceutical product life cycle.

• Ensures that tasks assigned to Pharmacovigilance are executed accurately.

• Offers medical advice to team members, clients, and investigators, addressing study-related medical inquiries.

• Conducts therapeutic and protocol training for assigned studies.

• Drafts and/or reviews Clinical Study Reports (CSRs), Investigational New Drug (IND)/New Drug Application (NDA) reports, Individual Case Safety Reports (ICSRs), signal detection reports, periodic reports, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), Common Technical Document (CTD) modules, and related documentation.

• Monitors safety metrics including adverse events, laboratory abnormalities, changes in patient medical conditions, concomitant medications, and unblinding requests.

• Engages with principal investigators and clients to discuss medical issues and interpret inclusion/exclusion criteria.

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

• Conducts data reviews and validation, including coding listings and comprehensive safety-data analysis for potential safety issues.

• Oversees signal detection activities and creates aggregate reports.

• Contributes to updates of labels, dossier management, and risk management initiatives.

• Medically evaluates adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.

• Participates in and presents at investigator and sponsor meetings, while also supporting business development efforts.

• Aids in departmental process enhancement initiatives.

• Acts as a consultant and representative for significant functional matters.

⛳️ Requirements

• MD or an equivalent qualification is required.

• Active medical licensure is preferred.

• Clinical experience in treating patients in hematology oncology or a related subspecialty, equivalent to approximately 2 years.

• Relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, equivalent to 1–2 years; or direct experience in safety/Pharmacovigilance, equivalent to 2 years.

• Familiarity with clinical trial regulations and ICH guidelines.

• Understanding of client SOPs/directives and project-specific Working Procedure Documents (WPDs).

• Capability to provide medical consultation and therapeutic/protocol training.

• Proficiency in reviewing safety and efficacy data as well as medical content in CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules.

• Medical knowledge in adverse events, serious adverse events, clinical outcomes, safety data reviews, and signal detection.

🏝️ Benefits

• Fully remote work setup.

• Standard Monday–Friday work hours.