Medical Director/Senior Medical Director – Endocrinology

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Provide medical oversight for clinical trials to guarantee adherence to SOPs, client directives, good clinical practices, and regulatory standards.

• Manage and oversee contracted services effectively.

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

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

• Assist in business development initiatives.

• Conduct medical reviews and analyses of serious adverse events in clinical trials.

• Ensure that tasks assigned to medical monitors are executed correctly.

• Monitor adverse events, laboratory abnormalities, patient medical conditions, concomitant medications, and un-blinding requests.

• Engage in discussions about medical concerns with principal investigators and clients, applying medical judgment to clinical scenarios.

• Medically review adverse events of special interest, serious adverse events, and clinical outcome events.

• Perform data review and validation, including coding listings and safety data, to spot potential safety issues.

• Provide therapeutic and protocol training.

• Write or review Clinical Study Reports (CSRs), IND/NDA reports, Individual Case Safety Reports (ICSRs), signal detection reports, periodic reports, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), and Common Technical Document (CTD) modules.

• Manage signal detection activities and scientifically review aggregate reports.

• Contribute to updates in labeling, dossier maintenance, and risk management efforts.

• Medically review adverse-event and serious-adverse-event data sourced from solicited, spontaneous, and literature references.

⛳️ Requirements

• MD or an equivalent qualification is mandatory.

• Formal training in Endocrinology Diabetes & Metabolism (residency and/or fellowship) is required.

• Patient treatment experience equivalent to 2 years is necessary.

• For the Senior Medical Director position: relevant clinical trial experience in a Contract Research Organization (CRO), pharmaceutical company, or as a principal investigator comparable to 1–2 years, or direct safety/Pharmacovigilance experience equivalent to 2 years.

• Active medical licensure is preferred but not mandatory.

• Must be legally eligible to work in the United States or Canada without sponsorship.

• Must be capable of passing a comprehensive background check, including drug screening when applicable.

• Therapeutic expertise in Neurology is required.

• Familiarity with relevant safety databases, such as MedDRA, is essential.

• Understanding of FDA, ICH, EMA, and GCP guidelines is necessary.

• Working knowledge of biostatistics, data management, and clinical operations procedures is required.

• Proficiency in basic computer applications is necessary.

• Fluency in spoken and written English is required.

• Ability to travel both domestically and internationally is essential.

• Capability to work independently, analyze and prioritize sensitive complex information, and multitask is important.

• Excellent oral and written communication, interpersonal, influencing, and team-building skills are necessary.

• Ability to mentor and train other staff members is required.

🏝️ Benefits

• Annual incentive plan bonus.

• Comprehensive healthcare coverage.

• A variety of employee benefits.

• Opportunities for career advancement and development.

• Innovative and forward-thinking company culture.