Medical Director – Dermatology

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🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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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, project team members, and associates • Support business development activities • Provide medical review and analysis for clinical trial 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 in writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documents • Monitor safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and un-blinding requests • Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical-study decisions • Review adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites • Perform data review and validate coding listings/full safety data to assess 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 • 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 • Therapeutic expertise across 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, e.g. MedDRA • Flexibility to travel domestically and internationally • Ability to work independently and analyze and prioritize sensitive, complex information • Proficiency in basic computer applications • Fluent in 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 • In some cases, an equivalency combining appropriate education, training, and/or directly related experience may be considered

🏖️ Benefits

• Resources to achieve individual career goals • Healthy and balanced work environment support • Mentoring/training opportunities