Senior Medical Director – Endocrinology

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice and regulatory requirements are followed • Attend and present at investigator and sponsor meetings • Provide medical consultation to clients, investigators, project team members and associates • Support business development activities • Manage medical aspects of contracted tasks across the pharmaceutical product life cycle • Ensure PV-delegated tasks are properly executed and comply with regulations, ICH guidelines, client directives and SOPs • 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, patient medical status, concomitant medications and unblinding requests • Discuss medical concerns with principal investigators and clients and make study-related medical decisions • Review adverse events of special interest, serious adverse events and clinical outcomes events • Perform contracted data review and validate coding listings and safety data • Manage signal detection activities and review aggregate reports • Contribute to label updates, dossier maintenance and risk management activities • Medically review adverse-event data from solicited, spontaneous and literature sources

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Medical Director candidates: clinical experience in the relevant specialty/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 candidates: clinical experience in the relevant specialty/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 in one or more medical specialties or sub-specialties • Working knowledge of relevant safety databases, such as MedDRA • Working knowledge of biostatistics, data management, and clinical operations procedures • Understanding of FDA, ICH, EMA and GCP guidelines • Proficiency in basic computer applications • Fluent spoken and written English • Ability to travel domestically and internationally • Ability to work independently and analyze and prioritize sensitive, complex information • Strong decision-making, problem-solving, organizational, analytical, communication, interpersonal, influencing and team-building skills • Ability to mentor/train other staff within PV

🏖️ Benefits

• Global team environment • Resources to achieve individual career goals • Collaboration and professional development opportunities • Occasional domestic and international travel • Healthy and balanced work environment

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