Medical Director/Senior Medical Director – Endocrinology

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

📋 Description

• Ensure medical oversight of clinical trials to adhere to SOPs, client directives, good clinical practices, and regulatory standards.

• Oversee and manage contracted services effectively.

• Attend and deliver presentations at investigator and sponsor meetings.

• Offer medical consultation to clients, investigators, project teams, and associates.

• Assist in business development initiatives.

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

• Guarantee that delegated medical-monitor tasks are executed correctly.

• Provide training related to therapeutic areas and protocols.

• Draft and/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.

• Monitor safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and unblinding requests.

• Engage in discussions regarding medical concerns with principal investigators and clients while interpreting inclusion/exclusion criteria.

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

• Conduct data reviews and validations, encompassing coding listings and comprehensive safety data assessments.

• Manage signal detection operations and evaluate aggregate reports for marketed products.

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

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

⛳️ Requirements

• An MD or equivalent is required.

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

• Comparable patient treatment experience of at least 2 years is required.

• For the Senior Medical Director position: 1–2 years of relevant clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator, or 2 years of direct safety/Pharmacovigilance experience.

• Active medical licensure is preferred but not mandatory.

• Therapeutic expertise in Neurology is necessary.

• Strong skills in decision-making, problem-solving, organization, and analysis are required.

• Excellent verbal and written communication skills are essential.

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

• Willingness to travel domestically and internationally is required.

• Ability to work independently and prioritize sensitive, complex information is essential.

• Proficiency in basic computer applications is expected.

• Fluency in spoken and written English is required.

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

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

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

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

• Must successfully pass a comprehensive background check, including drug screening where applicable.

• Regular and consistent attendance is expected.

• Capability to perform office-based physical and computer-related tasks, including occasional lifting of 15–20 lbs, is necessary.

🏝️ Benefits

• Annual incentive plan bonus.

• Comprehensive healthcare benefits.

• Employee benefits package.

• Opportunities for career and professional development.

• A culture that fosters innovation and forward-thinking.