Senior Medical Director – Cardiology

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

📋 Description

• Lead the medical aspects of study teams by developing clinical trial protocols and integrating the latest scientific insights.

• Assist in the selection of study sites.

• Participate in the evaluation and endorsement of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), decisions on protocol deviations, and other clinical documentation necessary for conducting clinical trials.

• Ensure the medical validity of each primary endpoint as well as the safety of study participants, while promptly identifying medical issues.

• Actively address customer concerns and resolve issues in collaboration with the Global Medical Indication Lead.

• Consult with internal teams and support staff regarding procedural and budgetary matters, as well as the need for changes due to any protocol amendments.

• Act as the primary liaison between the sponsor and all internal departments at PPD, ensuring all required tasks are completed throughout all phases of the study.

• Provide education to investigator sites by delivering presentations and demonstrations of protocol-specific lab procedures during investigator meetings.

• Manage daily activities throughout the clinical trial, addressing any challenges and responding to inquiries.

• Serve as the medical point of contact for all internal and external stakeholders: engage with investigators as necessary, respond to questions from IRBs and Health Authorities, prepare and present materials to the study executive and independent safety committee if applicable, conduct medical training for site staff at Investigator meetings, and provide CRA training on new indications.

• Ensure compliance with all medical aspects of the study by understanding and implementing all relevant SOPs and GCP.

• Collaborate closely with cross-functional study team members to ensure clarity on medical risks, issues, and results for all parties involved.

⛳️ Requirements

• Medical Doctor specializing in Cardiology.

• Proven clinical experience managing Cardiology patients in hospital settings.

• Required industry experience in clinical development.

• Extensive background in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.

• Proficient in both spoken and written English.

• Demonstrated understanding and experience with the NDA submission process.

• Familiarity with regulatory guidelines pertaining to adverse event reporting.

• Excellent communication and presentation skills, with a strong ability to work effectively as part of a team.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.