Senior Medical Director, Medical Monitor

Thermo Fisher Scientific

. Provide medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements .

Posted 9/30/2026full-timeRemote • TaiwanSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical oversight of clinical trials, ensuring compliance with regulatory requirements and good clinical practice. Possesses strong clinical experience in hema oncology and safety/Pharmacovigilance, with the ability to provide medical consultation and support clinical decision-making.

Highest-signal resume keywords

MD Or EquivalentClinical Trial ExperiencePharmacovigilance ExpertiseMedical ConsultationRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical OversightClinical Trial ManagementAdverse Event ReviewSignal DetectionData Review and ValidationProtocol TrainingCSR WritingRisk ManagementPatient Safety MonitoringRegulatory Reporting

Soft Skills

Independent JudgmentProblem SolvingConsultative CommunicationNetwork DevelopmentTeam Collaboration

Certifications & Qualifications

Active Medical Licensure

Industry Keywords

Good Clinical PracticeICH GuidelinesPharmaceutical Product Life CycleContract Research OrganizationHema OncologyClinical Decision-MakingCorporate PoliciesStudy-Related Medical QuestionsPeriodic ReportsDossier Maintenance

About the role

Key responsibilities & impact

Provide medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements
Manage all medical aspects of contracted tasks across the pharmaceutical product life cycle
Ensure tasks delegated to Pharmacovigilance are properly executed
Adhere to applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies
Provide medical consultation to team members and answer study-related medical questions
Provide therapeutic and protocol training on assigned studies
Assist in writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documents
Contribute to departmental process improvement initiatives
Monitor safety variables, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests
Discuss medical concerns with principal investigators and clients and support clinical decision-making
Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events
Perform contracted data review and validation, including coding listings and/or full safety data
Manage signal detection activities and generate aggregate reports
Contribute to label updates, dossier maintenance, and risk management activities
Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources
Attend and present at investigator and sponsor meetings
Provide medical consultation to clients, investigators, and project team members
Support business development activities

Requirements

What you’ll need

MD or equivalent required
Active medical licensure preferred
Clinical experience treating patients in hema oncology or a related sub-specialty, 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
Broad expertise or unique knowledge in the functional area
Ability to develop solutions to highly complex and unique issues
Ability to exercise independent judgment in methods, techniques, and evaluation criteria
Ability to serve as a consultant and spokesperson on highly significant matters
Ability to create formal networks with key decision makers

Benefits

Comp & perks

Fully remote work arrangement
Full-time employment