Medical Director – Dermatology

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🌐 Argentina, Brazil, +4 more countries – Remote

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

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 10%

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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, good clinical practice 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 for clinical trial serious adverse events, marketed-product ICSRs and periodic safety reports • Ensure tasks delegated to Pharmacovigilance are properly executed and comply with regulations, ICH guidelines, client directives and company procedures • Answer study-related medical questions and maintain communication with associates and clients • 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 deliverables • Monitor safety variables including adverse events, laboratory abnormalities, patient medical status, concomitant medication restrictions and unblinding requests • Discuss medical concerns with principal investigators and clients and make clinical-study decisions using medical judgment • Review adverse events of special interest, serious adverse events and clinical outcome events • Perform data review, including coding listings and/or full safety data, to assess potential safety concerns • Manage signal detection activities and scientifically review aggregate reports • Contribute to label updates, dossier maintenance and risk-management activities • Medically review adverse-event and serious-adverse-event data from solicited, spontaneous and literature sources

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • Clinical experience in the relevant specialty or sub-specialty, comparable to 2 years • Or 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 • For Senior Medical Director: clinical experience comparable to 2 years plus suitable clinical trial experience comparable to 1–2 years or direct safety/Pharmacovigilance experience comparable to 2 years • Equivalency through a combination of 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 (e.g. MedDRA) • Flexibility to travel domestically and internationally • Proficiency in basic computer applications • Fluent in spoken and written English • Understanding of FDA, ICH, EMA and GCP guidelines • Working knowledge of biostatistics, data management and clinical operations procedures • Ability to mentor/train other staff within PV

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Opportunities to support meaningful work and life-changing therapies • Career development resources and support • Occasional domestic and international travel