DIRECTOR - CLINICAL DEVELOPMENT (MEDICAL MONITORING)

Akerotherapeutics

mid€187,100-327,500/year

Job description

<div class="content-intro">COMPANY BACKGROUND 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). 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.</div>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. Job Responsibilities <ul> <li 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</li> <li style="font-family: helvetica, arial, sans-serif;">Play an active role in planning, conduct and evaluation of ongoing clinical trials to ensure successful execution</li> <li 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.</li> <li 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)</li> <li 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)</li> <li 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</li> <li style="font-family: helvetica, arial, sans-serif;">Contribute to engagement with external stakeholders such as vendor thought leaders or other groups as needed including being the primary liaison with assigned individuals or groups.</li> <li style="font-family: helvetica, arial, sans-serif;">Function as an independent member of the team and represent clinical development at internal cross-functional or external meetings</li> <li style="font-family: helvetica, arial, sans-serif;">Other duties related to clinical development of EFX as assigned</li> </ul> Qualifications <ul> <li style="font-family: helvetica, arial, sans-serif;">Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience <ul> <li style="font-family: helvetica, arial, sans-serif;">Experience in hepatology, MASH or internal medicine preferred</li> </ul> </li> <li style="font-family: helvetica, arial, sans-serif;">Minimum of 3 years of relevant experience in clinical development in the biotech and/or pharmaceutical industry; five (5) years preferred</li> <li style="font-family: helvetica, arial, sans-serif;">Direct experience in executing and medical monitoring of clinical trials, experience with Phase 3 trials is highly desirable</li> <li style="font-family: helvetica, arial, sans-serif;">Relevant experience: <ul> <li>Solid knowledge of GCP, ICH guidelines and FDA/EMA/CHMP regulations, with the ability to apply these principles and standards to ensure GCP-compliant trials.</li> <li>Strong interpersonal and communication skills, with a proactive, collaborative approach.</li> <li>Skilled at searching, critically evaluating, interpreting and synthesizing scientific literature and clinical trial data.</li> <li>Demonstrated problem-solving ability and ownership of issues to drive timely resolution; adaptable, high attention to detail, and effective under time and resource constraints.</li> <li>Comfortable working independently and as part of cross-functional teams, including engagement with external vendors.</li> <li>Highly organized with strong prioritization and time-management skills; able to manage multiple projects concurrently.</li> <li>Advanced proficiency in Microsoft Office (Word, Excel, PowerPoint).</li> </ul> </li> <li style="font-family: helvetica, arial, sans-serif;">Experience with preparation of documentation for BLA/NDA/MAA submissions desirable</li> <li style="font-family: helvetica, arial, sans-serif;">Knowledge of the regulatory path across the various health authorities (FDA, EMA etc) desirable</li> </ul> The base compensation range for this position is $187,100 to $327,500. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Akero Therapeutics, a Novo Nordisk company, offers long-term incentive compensation depending on the position's level or other company factors. Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy. The job posting is anticipated to close on September 1, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at <a href="https://akerotx.com/job-opportunities/">https://akerotx.com/job-opportunities</a>. EEO Statement: Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

Skills

GCPICH guidelinesFDA regulationsEMA regulationsCHMP regulationsBLANDAMAAMicrosoft OfficeWordExcelPowerPoint