Medical Director – Senior Medical Director, Cardiology
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Job Description
Medical Director overseeing cardiology clinical trials and pharmacovigilance at Thermo Fisher Scientific. Reviewing safety data, regulatory reports, and medical decisions across global studies.
Responsibilities:
- 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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