Medical Director/Sr Medical Director – Cardiology

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee all medical components of contracted assignments throughout the pharmaceutical product life-cycle.

• Ensure that tasks assigned to Pharmacovigilance (PV) are executed effectively.

• Comply with relevant regulations and ICH guidelines concerning clinical trials, regulatory documentation, and safety matters.

• Follow client-specific SOPs/directives and project-related WPDs for the projects assigned.

• Adhere to CRG’s corporate policies and SOPs/WPDs.

• Offer medical guidance to team members and address all medical inquiries related to the study.

• Maintain clear communication with colleagues and clients, ensuring all procedures are properly adhered to.

• Provide therapeutic and protocol training on assigned studies as needed.

• Assist in drafting (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 verify that the medical content is both accurate and comprehensive.

• Supervise all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) in clinical studies.

• Address all medical issues with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) that arise during the study, applying sound medical judgment in interpretation and decision-making regarding clinical situations relevant to the investigational study.

• Conduct medical reviews of adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites.

• Execute data review as outlined in the client contract and data validation manual, including assessments of coding listings and/or full safety data to identify potential safety concerns.

• Manage signal detection activities, scientifically evaluate aggregate reports, contribute to label updates, and assist in dossier maintenance and risk management tasks.

• Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as per contract obligations.

⛳️ Requirements

• MD or equivalent is required.

• Active medical licensure is preferred but not mandatory.

• Clinical experience in treating patients in the relevant specialty or sub-specialty (e.g., Cardiology residency/fellowship) associated with the applicant's training (approximately 2 years).

• Relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (approximately 1-2 years) in the industry.

• Direct experience in safety/Pharmacovigilance (approximately 2 years).

• For Senior Medical Director: Candidates should possess a blend of clinical experience and industry experience, including clinical experience in treating patients in the relevant specialty or sub-specialty (e.g., Cardiology residency/fellowship) associated with the applicant's training (approximately 2 years) and one of the following: Relevant clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (approximately 1-2 years) in the industry; or Direct experience in safety/Pharmacovigilance (approximately 2 years).

🏝️ Benefits

• Health insurance

• Paid time off

• Flexible working arrangements

• Professional development opportunities