Medical Director/Sr Medical Director – Cardiology

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🕒 May 14

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

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

• Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle. • Ensure tasks delegated to PV are properly executed. • Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. • Follow client SOPs/directives and project-specific WPDs for assigned projects. • Comply with CRG’s corporate policies and SOPs/WPDs. • Provide medical consultation to team members and answer all study-related medical questions. • Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. • Provide therapeutic training and protocol training on assigned studies, as requested. • Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete. • Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. • Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study. • Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites. • Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns. • Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities. • Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

🎯 Requirements

• MD or equivalent required. • Active medical licensure preferred but not required. • Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years). • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry. • Direct experience in safety/Pharmacovigilance (comparable to 2 years). • For Senior Medical Director: Candidates should have a combination of clinical experience and industry experience as follows: Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years) and one of the following: Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or Direct experience in safety/Pharmacovigilance (comparable to 2 years).

🏖️ Benefits

• Health insurance • Paid time off • Flexible working arrangements • Professional development opportunities