Akero Therapeutics

Medical Director

• Serve as Medical Monitor for assigned clinical trials, conducting ongoing review of emerging medical and safety data and working closely with external CRO partners
• Play an active role in planning, conducting and evaluating ongoing clinical trials
• Support or manage preparation of materials for trial-related clinical committees, including Data Monitoring Committees and Adjudication Committees
• Contribute to planning, authoring and critical review of documents submitted to regulatory authorities and ethics committees/IRBs, including protocols, CSRs, Investigator’s Brochures, DSURs, clinical briefing documents and BLA/MAA submission components
• Contribute to strategic planning, authoring and critical review of scientific data disclosures, including slide presentations, posters and publications
• Develop professional relationships with external clinical opinion leaders, investigators and consultants
• Stay abreast of competitive intelligence and market/industry activities
• Engage with external stakeholders such as vendor thought leaders and serve as primary liaison with assigned individuals or groups
• Represent clinical development at internal cross-functional and external meetings
• Perform other duties related to clinical development of EFX as assigned

Director – Clinical Development, Medical Monitoring

Clinical Operations

• Lead TMF activities for assigned trials across start-up, maintenance, close-out, and archive phases, ensuring consistent communication with Clinical Trial Teams (CTT) and CRO partners.
• Oversee implementation and maintenance of processes for cataloging, filing, retrieval, storage, preservation, and protection of TMF records (electronic and paper) and CTMS outputs.
• Manage eTMF health by overseeing Quality Issue (QI) workflows, ensuring timely remediation of QC/QR findings, including closing or reassigning QIs as appropriate.
• Govern Expected Document Lists (EDL), including completeness, accuracy, and reconciliation of document counts in collaboration with CTT and CRO teams.
• Monitor compliance with TMF business processes and escalate risks or non-compliance to Clinical Operations and Quality leadership as needed.
• Deliver scheduled and ad hoc TMF health metrics, analysis, and insights to support trial teams and leadership decision-making.
• Ensure TMF inspection readiness through ongoing quality oversight, including ad hoc QC reviews of uploaded documents and maintenance of filing/naming conventions aligned with the TMF Reference Model.
• Provide subject matter expertise (SME) for audits and inspections, including preparation, support, and remediation activities.
• Maintain current knowledge of regulatory requirements, TMF Reference Model standards, and industry best practices.
• Support TMF document processing, including filing oversight, troubleshooting, and responding to TMF-related inquiries.
• Participate in trial-specific and departmental meetings, providing TMF expertise and status updates.
• Perform general operational and administrative activities to support assigned trials.
• Contribute to TMF strategy, planning, and continuous improvement initiatives, including development of processes, tools, and training for TMF stakeholders.
• Support Clinical Operations leadership on high-impact projects and organizational initiatives.
• Supervise TMF operations, proactively identify risks, anticipate challenges, and implement mitigation strategies to ensure delivery of team and project goals.

Clinical TMF Operations Administrator

• 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 across internal teams and external partners
• Provide direct supervision and periodic review of work for departmental employees, to ensure oversight and execution of clinical development timelines
• Direct and mentor a team of data management professionals.
• Foster a collaborative environment that encourages innovation and knowledge sharing.
• Ensure effective resource allocation and management across research departments.
• Drive performance and accountability through clear communication of expectations and goals
• Support organizational growth by scaling data management capabilities and processes as the portfolio evolves

Director – Clinical Development, Medical Monitoring

Clinical TMF Operations Administrator

Senior Director, Clinical Data Management