Senior Medical Director – Endocrinology

Thermo Fisher Scientific

. Provide medical oversight of clinical trials to ensure SOPs, client directives, GCP and regulatory requirements are followed .

Posted 9/21/2026full-timeRemote • Mexico, Brazil, Peru, Colombia, Argentina, ChileSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical oversight of clinical trials, ensuring compliance with GCP, FDA, ICH, and EMA guidelines. Proficient in pharmacovigilance, safety reporting, and medical consultation across various therapeutic areas.

Highest-signal resume keywords

MD Or EquivalentClinical Trial ExperiencePharmacovigilance ExperienceTherapeutic ExpertiseFluent English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Medical ReviewSignal DetectionAdverse Event AnalysisData ManagementBiostatisticsClinical Operations ProceduresProtocol TrainingCSR WritingIND/NDA ReportingRisk Management

Soft Skills

Decision-MakingProblem-SolvingOrganizational SkillsInterpersonal SkillsTeam-Building

Tools & Technologies

MedDRASafety DatabasesBasic Computer Applications

Certifications & Qualifications

Active Medical Licensure

Industry Keywords

GCPFDA GuidelinesICH GuidelinesEMA GuidelinesClinical TrialsPharmaceutical Product Life-CycleSerious Adverse EventsPeriodic Safety ReportsInvestigational StudiesClinical Outcomes

About the role

Key responsibilities & impact

Provide medical oversight of clinical trials to ensure SOPs, client directives, GCP and regulatory requirements are followed
Attend and present at investigator and sponsor meetings
Provide medical consultation to clients, investigators and project team members
Support business development activities
Provide medical review and analysis of serious adverse events, marketed-product ICSR and periodic safety reports
Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle
Ensure pharmacovigilance tasks are properly executed and comply with regulations, ICH guidelines, client SOPs and project procedures
Answer study-related medical questions and maintain communication with associates and clients
Provide therapeutic and protocol training
Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules and related deliverables
Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, medical-status changes, concomitant medications and unblinding requests
Discuss medical concerns with principal investigators and clients and make clinical decisions relating to investigational studies
Review adverse events of special interest, serious adverse events and clinical outcomes reported by study sites
Perform contracted data review and assess potential safety concerns
Manage signal detection, review aggregate reports, contribute to label updates and support dossier maintenance and risk management
Medically review adverse-event and serious-adverse-event data from solicited, spontaneous and literature sources

Requirements

What you’ll need

MD or equivalent required
Active medical licensure preferred
Medical Director: clinical experience treating patients in the relevant specialty or sub-specialty comparable to 2 years; or suitable clinical trial experience comparable to 1–2 years; or direct safety/Pharmacovigilance experience comparable to 2 years
Senior Medical Director: clinical experience in the relevant specialty or sub-specialty comparable to 5 years plus suitable clinical trial experience comparable to 4–5 years or direct safety/Pharmacovigilance experience comparable to 5 years
Equivalency through appropriate education, training and/or directly related experience may be considered
Therapeutic expertise across one or more medical specialties or sub-specialties
Working knowledge of relevant safety databases, such as MedDRA
Flexibility to travel domestically and internationally
Fluent spoken and written English
Understanding of FDA, ICH, EMA and GCP guidelines
Working knowledge of biostatistics, data management and clinical operations procedures
Proficiency in basic computer applications
Ability to work independently and process complex sensitive information
Strong decision-making, problem-solving, organizational and analytical skills
Excellent oral and written communication skills
Excellent interpersonal, influencing and team-building skills
Ability to mentor/train other staff within PV

Benefits

Comp & perks

Global team environment
Resources to achieve individual career goals
Collaboration and professional development opportunities
Health and wellbeing support
Healthy and balanced work environment
Scientific excellence-focused workplace