Sr. Director, Clinical Data Management

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. Akero Therapeutics is developing medicines that deliver transformational outcomes to patients with serious metabolic diseases. Our lead clinical program, Efruxifermin (EFX), is a treatment for non-alcoholic steatohepatitis (NASH), rapidly emerging as the leading cause of liver disease around the world. Efruxifermin is a novel long-acting fibroblast growth factor 21 (FGF21) agonist, with the potential to substantially improve the lives of patients with NASH, and other serious metabolic diseases. 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. The Senior Director, Clinical Data Management is a key member of Clinical Development and will closely partner with the Head of Development Operations. The Senior Director of Clinical Data Management provides strategic leadership and oversight for all clinical data management activities across the development program. This role partners closely with leaders from Clinical Operations, Biostatistics, Regulatory, Medical, and other functional areas to proactively solve cross-functional challenges, ensure data integrity, and support timely, high-quality decision making. The Senior Director is accountable for end-to-end vendor oversight, data governance, and the delivery of reliable, inspection-ready clinical data. Reports to the VP, Clinical Research and Medical Affairs. Manages a team of clinical data management professionals. The position will interact with all areas of Clinical and Regulatory Affairs within Akero Therapeutics and Novo Nordisk. The position interacts with team members at the IC through Vice President level. The position requires experience interacting with senior level positions in each of these departments and a good understanding of how these peer teams operate, ideally through experience working within these teams (broad experience). Externally, the position will engage with CROs and CMOs Job Responsibilities Serve as a senior thought partner to functional leaders, contributing to program-level planning, risk mitigation, and execution strategies. Collaborate across Clinical Operations, Biostatistics, Medical, Regulatory, Safety, and Quality to identify and resolve data-related issues impacting timelines, quality, or compliance Set up data management vendors as required, including authoring of RFPs, reviewing and negotiating data management budgets and contracts Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines to support program timelines Oversee data review, cleaning, and database lock activities to ensure accuracy and readiness for analysis and regulatory submission Proactively identify vendor risks, escalate issues as needed, and drive root-cause analysis and corrective actions Balance quality, timelines, and cost while driving pragmatic solutions aligned with program priorities Foster a culture of accountability, collaboration, and continuous improvement ac…