Director - Clinical Development (Medical Monitoring)

<div class="content-intro"><p><strong>COMPANY BACKGROUND</strong></p> <p>Akero Therapeutics, a Novo Nordisk company, is a clinical stage biopharmaceutical company focused on discovering and developing transformational treatments for patients with serious metabolic diseases marked by high unmet need. Our current focus is on advancing our lead program efruxifermin (EFX) to provide a powerful new treatment for patients with MASH(metabolic dysfunction-associated steatohepatitis).<br>We are a team of problem solvers dedicated to pursuing bold scientific approaches to build a brighter future for patients. Our diverse skill sets and backgrounds, desire to learn from each other and collaborative spirit breed a culture where everyone feels inspired to bring their best thinking to work, and to bring out the best in others.</p></div><p><span style="font-family: helvetica, arial, sans-serif;">Reporting to the VP Clinical Development, the Director, Clinical Development will contribute to the execution of the Phase 3 clinical development programme for Efruxifermin (EFX). Key responsibilities include, but are not limited to clinical trial execution, medical monitoring, data analysis and reporting of results for regulatory submissions or scientific presentations and publications. They will be responsible for clinical guidance within the organization and will serve as a medical expert both internally and externally. This position demands strong collaborative and communication skills, high attention to detail, a willingness to “roll up your sleeves” and the ability to engage with a diverse range of internal and external stakeholders.</span></p> <p> </p> <p> </p> <p><span style="font-family: helvetica, arial, sans-serif;"><strong>Job Responsibilities</strong></span></p> <ul> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical/safety data and working closely with external CRO partners</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Support/manage preparation of materials for trial-related clinical committees such as Data Monitoring Committees, Adjucation Committees, etc.</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Contribute to planning, authoring, and critical review of documents submitted to regulatory authorities and ethics committee/IRBs as required (e.g., Protocols, CSRs, Investigator’s Brochure, DSURs, clinical briefing documents, components of BLA/MAA submissions)</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Contribute to the strategic planning, authoring, and critical review of scientific data disclosures (e.g., slide presentations, posters and publications)</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities</span></li> <li style="font-family: helvetica, arial, sans-serif;"><span style="font-family: helvetica, arial, sans-serif;">Contribute