Medical Director/Sr Medical Director – Cardiology
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Job Description
Medical Director overseeing medical aspects of clinical trials at Thermo Fisher Scientific. Ensuring compliance with regulations and delivering high-quality medical oversight in the pharmaceutical product life-cycle.
Responsibilities:
- 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
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