Senior Medical Director, Medical Monitor

🔥 0 minutes ago

🌐 Philippines, Malaysia – Remote

🇵🇭 Philippines – Remote 🇲🇾 Malaysia – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provides medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements • Manages all medical aspects of contracted tasks across the pharmaceutical product life cycle • Ensures tasks delegated to Pharmacovigilance are properly executed • Provides medical consultation to team members, clients, and investigators and answers study-related medical questions • Provides therapeutic and protocol training on assigned studies • Writes and/or reviews CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documents • Monitors safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and unblinding requests • Discusses medical concerns and interprets inclusion/exclusion criteria with principal investigators and clients • Reviews adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites • Performs data review and validation, including coding listings and full safety-data review for potential safety concerns • Manages signal detection activities and generates aggregate reports • Contributes to label updates, dossier maintenance, and risk-management activities • Medically reviews adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources • Attends and presents at investigator and sponsor meetings and supports business-development activities • Contributes to departmental process-improvement initiatives • Serves as a consultant and spokesperson for significant functional matters

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Clinical experience treating patients in hematology oncology or a related subspecialty, comparable to 2 years • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years; or direct experience in safety/Pharmacovigilance, comparable to 2 years • Knowledge of clinical trial regulations and ICH guidelines • Knowledge of client SOPs/directives and project-specific WPDs • Ability to provide medical consultation and therapeutic/protocol training • Ability to review safety and efficacy data and medical content in CSR, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Medical expertise in adverse events, serious adverse events, clinical outcomes, safety data review, and signal detection

🏖️ Benefits

• Fully Remote work arrangement • Standard Monday–Friday work schedule