Medical Director/Senior Medical Director – Endocrinology

🔥 13 hours ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $200k - $278.9k / year

⏰ 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 • Manage and oversee contracted services • Attend and present at investigator and sponsor meetings • Provide medical consultation to clients, investigators, project teams, and associates • Support business development activities • Provide medical review and analysis of clinical trial serious adverse events • Ensure delegated medical-monitor tasks are properly executed • Provide therapeutic and protocol training • Write and/or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules • Monitor 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 interpret inclusion/exclusion criteria • Review adverse events of special interest, serious adverse events, and clinical outcome events • Perform data review and validation, including coding listings and full safety data review • Manage signal detection activities and review aggregate reports for marketed products • 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 • Formal training in Endocrinology Diabetes & Metabolism (residency and/or fellowship) • Patient treatment experience comparable to 2 years • For Senior Medical Director: 1–2 years of suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator, or 2 years of direct safety/Pharmacovigilance experience • Active medical licensure preferred but not required • Therapeutic expertise in Neurology • 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 prioritize sensitive, complex information • 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 • Must be legally authorized to work in the United States or Canada without sponsorship • Must be able to pass a comprehensive background check, including drug screening where applicable • Regular and consistent attendance • Ability to perform office-based physical and computer-related duties, including occasional lifting of 15–20 lbs

🏖️ Benefits

• Annual incentive plan bonus • Healthcare • Employee benefits • Career and development prospects • Innovative, forward-thinking company culture