Senior Medical Director – Endocrinology

🔥 0 minutes ago

🌐 Mexico, Brazil, +4 more countries – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote 🇵🇪 Peru – Remote 🇨🇴 Colombia – Remote 🇦🇷 Argentina – Remote 🇨🇱 Chile – 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

• 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

• 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

• 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