Medical Director – Dermatology

🔥 26 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 12%

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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, GCP, 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 • Provide medical review and analysis for serious adverse events, marketed-product ICSRs, periodic safety reports, and other client deliverables • Ensure tasks delegated to Pharmacovigilance are properly executed • Follow applicable regulations, ICH guidelines, client SOPs/directives, project WPDs, and corporate policies • Provide therapeutic and protocol training on assigned studies • Assist with writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Monitor clinical-trial safety variables, including adverse events, laboratory abnormalities, patient medical-status changes, concomitant medications, and unblinding requests • Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical-study situations • Medically review adverse events of special interest, serious adverse events, and clinical outcome events • Perform contracted data review, including coding-listing and full-safety-data review, 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, literature, and other sources

🎯 Requirements

• MD or equivalent required • Active medical licensure preferred • At least one of: clinical experience treating patients in the relevant specialty/sub-specialty comparable to 2 years; suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator comparable to 1–2 years; direct safety/Pharmacovigilance experience comparable to 2 years • For Senior Medical Director: approximately 2 years of specialty clinical experience plus suitable clinical trial experience of 1–2 years or direct safety/Pharmacovigilance experience of 2 years • Therapeutic expertise in one or more medical specialties or sub-specialties • Strong decision-making, problem-solving, organizational, and analytical skills • Excellent oral and written communication skills • Working knowledge of relevant safety databases, such as MedDRA • Flexibility to travel domestically and internationally • Ability to work independently, analyze work with attention to detail, and prioritize sensitive, complex information • Proficiency in basic computer applications • Fluent spoken and written English • Excellent interpersonal, influencing, and team-building skills • 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 Pharmacovigilance • Equivalency combining appropriate education, training, and/or directly related experience may be considered

🏖️ Benefits

• Meaningful work with a positive global health impact • Resources to achieve individual career goals • Work-life health and wellbeing support • Fully remote work arrangement • Occasional domestic and international travel opportunities

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