Medical Director/Sr Medical Director – Cardiology

📋 Description

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

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

• Comply with relevant regulations and ICH guidelines pertaining to clinical trials, regulatory documents, and safety matters.

• Follow client Standard Operating Procedures (SOPs) and project-specific Work Procedure Documents (WPDs) for the projects assigned.

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

• Provide medical guidance to team members and address all study-related medical inquiries.

• Maintain clear communication with colleagues and clients, ensuring that all procedures are correctly followed.

• Offer therapeutic and protocol training on assigned studies, as needed.

• Assist in drafting (interpretation of safety and efficacy data) and/or reviewing Clinical Study Reports (CSR), Investigational New Drug/New Drug Application (IND/NDA) reports, Individual Case Safety Reports (ICSR), signal detection reports, periodic reports, Risk Management Plans (RMP), Risk Evaluation and Mitigation Strategies (REMS), Common Technical Document (CTD) modules, etc., ensuring that the medical content is precise and comprehensive.

• Monitor all safety variables (Adverse Events (AE), laboratory abnormalities, changes in patient medical status, evaluation of concomitant medications for protocol restrictions, and un-blinding requests) during clinical studies.

• Discuss medical issues with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) that arise throughout the study, applying sound medical judgment in the interpretation and decision-making relating to clinical situations pertinent to the investigational study.

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

• Perform data reviews as stipulated in the client contract and data validation manual, including examination of coding listings and/or full safety data to evaluate potential safety concerns.

• Oversee signal detection activities, scientifically review aggregate reports, contribute to label updates, and assist in dossier maintenance and risk management efforts.

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

⛳️ Requirements

• MD or equivalent degree required.

• Active medical licensure 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 and industry experience as follows: 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