Medical Director – Sleep Disorders

This is a fully remote position, open to applicants in Argentina, +4 more countries.

📋 Description

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

• Ensure that delegated pharmacovigilance responsibilities are executed correctly and in accordance with regulations, ICH guidelines, client instructions, and company SOPs/WPDs.

• Offer medical advice to team members and respond to inquiries related to study protocols.

• Liaise with associates and clients to guarantee adherence to established procedures.

• Deliver therapeutic and protocol training for designated studies.

• Assist in the writing and/or reviewing of Clinical Study Reports (CSRs), IND/NDA submissions, Individual Case Safety Reports (ICSRs), signal detection reports, periodic reports, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), Common Technical Document (CTD) modules, and other relevant deliverables.

• Monitor safety variables in clinical trials, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and requests for un-blinding.

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

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

• Conduct contracted data reviews and validations to identify potential safety issues.

• Manage signal detection operations and evaluate aggregate reports.

• Contribute to label updates, dossier maintenance, and risk management initiatives.

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

⛳️ Requirements

• Medical Doctor specializing in Neurology with a focus on Sleep disorders.

• Clinical experience in treating patients with Sleep disorders within a hospital setting.

• At least one of the following: clinical experience in the relevant specialty/sub-specialty equivalent to 2 years; appropriate clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator equivalent to 1–2 years; direct safety/Pharmacovigilance experience equivalent to 2 years.

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

• Strong background with Pediatric Investigation Plans (PIPs).

• Proficient in both spoken and written English.

• Familiarity with the NDA submission process.

• Knowledge of regulatory guidelines pertaining to adverse event reporting.

• Excellent communication and presentation abilities.

• In certain instances, an equivalency of relevant education, training, and/or directly related experience may be deemed adequate.

🏝️ Benefits

• Collaborative global team environment.

• Opportunities for collaboration and professional development.

• Meaningful work that contributes to healthier, cleaner, and safer outcomes.

• Resources available to help achieve individual career aspirations.

• Chance to contribute to scientific innovation and life-changing therapies.