Medical Director/Sr Medical Director - Cardiology(Remote)

What You'll Do

• Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• General Support:
  • 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.
• Clinical Trial Support:
  • 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.
• Marketed Products Support:
  • 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.
• Candidates should have at least one of the following:
  • 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:
  • 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).

Knowledge, Skills, Abilities

• Therapeutic expertise across one or more medical specialty or sub-specialties.
• Strong decision-making, problem solving, organizational skills and analytical skills.
• Excellent oral and written communication skills.
• Flexibility to travel domestically and internationally.
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information.
• Proficiency in basic computer applications.
• Fluent in spoken and written English.
• Excellent interpersonal, influencing and team building skills.
• Understanding guidelines (FDA, ICH, EMA and GCP).
• Working knowledge of biostatistics, data management, and clinical operations procedures.
• Ability to act as a mentor/trainer to other staff within PV.