Thermo Fisher Scientific
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.
Medical Director – Senior Medical Director, Cardiology
🔥 0 minutes ago
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Thermo Fisher Scientific
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, ensuring compliance with company SOPs, client directives, good clinical practice, and regulatory requirements • Attend and present at investigator and sponsor meetings • Provide medical consultation to clients, investigators, project teams, and team members • Support business development activities • Manage all medical aspects of contracted tasks across the pharmaceutical product life cycle • Ensure pharmacovigilance-delegated tasks are properly executed and follow applicable regulations, ICH guidelines, client SOPs, project WPDs, and corporate policies • Provide therapeutic and protocol training on assigned studies • 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, patient medical status, concomitant medications, and un-blinding requests • Discuss medical concerns with principal investigators and clients and make medical decisions regarding clinical situations • Medically review adverse events of special interest, serious adverse events, and clinical outcomes events • Perform data review and validate coding listings and 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, 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 CRO, pharmaceutical company, or as a principal investigator comparable to 1–2 years, or direct safety/pharmacovigilance experience comparable to 2 years • Combination of appropriate education, training, and/or directly related experience may be considered equivalent in some cases • 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, 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 and train other pharmacovigilance staff
🏖️ Benefits
• Global team environment • Collaboration and professional development opportunities • Reasonable accommodation for individuals with disabilities • Benefits and privileges of employment • Opportunity to contribute to life-changing therapies and scientific innovation
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