Medical Director/Senior Medical Director – Cardiology

📋 Description

• Oversee medical aspects of clinical trials to ensure adherence to company SOPs, client directives, good clinical practice, and regulatory standards.

• Participate in and present at meetings with investigators and sponsors.

• Offer medical consultation to clients, investigators, and project team members.

• Assist in business development initiatives.

• Conduct medical reviews and analyses for serious adverse events in clinical trials, marketed products ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR).

• Manage all medical responsibilities related to contracted tasks throughout the pharmaceutical product life-cycle.

• Ensure that tasks allocated to PV are executed properly.

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

• Follow client SOPs/directives and project-specific WPDs for designated projects.

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

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

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

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

• Assist in drafting (interpreting safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure the accuracy and completeness of medical content.

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

• Discuss all medical issues with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) arising during the study, applying appropriate medical judgment in the interpretation and decision-making related to clinical situations in the investigational study.

• Conduct data reviews 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 review aggregate reports, contribute to label updates, and assist in dossier maintenance and risk management activities.

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

⛳️ Requirements

• MD or equivalent degree is required.

• Active medical licensure is preferred but not mandatory.

• Clinical experience in treating patients within the relevant specialty or sub-specialty (e.g., Cardiology residency/fellowship) equivalent to 2 years.

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

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

• For Senior Medical Director: Candidates should possess a blend of clinical and industry experience, including clinical experience in treating patients within the relevant specialty or sub-specialty (e.g., Cardiology residency/fellowship) equivalent to 2 years, along with one of the following: suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator (equivalent to 1-2 years) in the industry; or direct experience in safety/Pharmacovigilance (equivalent to 2 years).

🏝️ Benefits

• We advocate for and support individuals in cultivating a healthy and balanced environment that enables them to thrive.