Akero Therapeutics

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. - The CTMA is a key member of Clinical Operations and will closely partner with the Senior Clinical Trial Manager. - Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking. - Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel. - Provides study level information to enable accurate and efficient supply of clinical product to the sites. - Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services. - Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings. - Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track. - May participate in review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies. - Provides regular study updates to the appropriate internal stakeholders. - Maintains internal Clinical Operations databases and document repositories. - Performs administrative duties in a timely manner as assigned. - Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations. - Adheres to Clinical Operations processes and SOPs Qualifications: - At least 2+ years of relevant experience and a BS or BA in a relevant scientific discipline OR - At least 2+ years of relevant experience and an RN (2- or 3-year certificate) Relevant Experience & Skills - Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent - Excellent attention to detail, verbal, written, interpersonal and presentation skills are required - Must be familiar with routine medical/scientific terminology - Must be familiar with Word, PowerPoint, and Excel - Must have working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials - Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision - High energy level, personal productivity, creativity and commitment. - Team-player with desire to work in a fast-moving, dynamic start-up environment. - This position is for remote work but may require domestic or international travel as required (valid travel documents must be obtainable). The base compensation range for this position is $81,010 to $145,820. 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 Feb 9, 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at https://akerotx.com/job-opportunities. 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.

• Design and oversee the execution of development studies to evaluate the optimal formulations and establish scalable, robust DP manufacturing processes. • Partner with CROs and CDMOs to manage drug product activities in preparation for process validation and registration. • Generate high quality data based on sound scientific principles, interpret data and communicate the results through technical reports, presentations, and regulatory documents. • Demonstrate ability to critically evaluate complex analytical and development data and lead troubleshooting of any formulation, process, and manufacturing challenges. • Design and execute in-use compatibility studies to support product use and label. • Author and review drug product sections for regulatory submissions, including original IND/IMPD, IND/IMPD amendments, BLA, and response to queries from global regulatory authorities, Investigator's Brochure and Pharmacy Manual. • Contribute to product quality review forums to define specifications and monitor product performance as measured by quality control testing. • Support clinical and commercial supply planning. • Interact effectively with members within Technical Operations, and cross-functional internal and external partners to ensure alignment of technical activities. • Drive project execution to meet key milestones, timelines, and deliverables.

• Operational oversight of analytical characterization activities within Akero through working closely with our global network of external analytical testing sites and manufacturing partners (CROs/CTLs/ CMOs) and colleagues in R&D, Quality Assurance, and Regulatory. • Develop and execute analytical heightened characterization studies and comparability assessments • Oversee phase-appropriate development, validation, and implementation of biologic analytical methods at CRO/CDMOs. • Work closely with QC on stability trending analysis and elucidation of product degradation pathways and specification setting. • Collaborate with cross-functional teams to develop CQA risk assessments and mitigation strategies for in-process control and post-licensure monitoring strategies. This includes working closely with downstream and process scientists/engineers to characterize both drug substance and drug product manufacturing processes. • Support preparation of regulatory submissions and regulatory engagement as technical subject matter expert as needed. • Monitor advancements and trends in analytical technology and applications in biologics characterization strategies that meets regulatory expectations.

• build and foster strong collaborative partnerships with CDMOs for drug substance process development, characterization and technology transfer activities • aid in developing robust drug substance manufacturing processes throughout the product life cycle for Akero products • ensure successful, right first time, transfer of process technologies to CDMOs and from one CDMO to another as required • ensure process development studies are conducted under approaches that are reflective of regulatory guidance and agency expectations and utilizing statistical and characterization methods that are appropriate for late-stage process development • review and approve DS related manufacturing documents, i.e. master batch records, change controls, plans, protocols, reports, and deviations as required • support process trending analysis for existing and next-generation manufacturing processes, tying process development knowledge and experience to GMP manufacturing performance • conduct CDMO site visits as required to support process development and technology transfer, conduct routine technical meetings with key stakeholders to coordinate development efforts and collaborate with partnering teams • author and/or review process development global health authority dossier sections for clinical trials and commercial licensure • interface with quality assurance to establish and maintain drug substance related procedural documents

• Oversee and drive CMC project plans, ensuring deliverables align with the overall project objectives and timelines • Facilitate cross-functional collaboration by leading CMC sub-team meetings, preparing agendas, tracking action items, and maintaining meeting minutes. • Partner with Technical Operations, Legal, and Finance to negotiate and execute confidentiality agreements, consulting agreements, master service agreements, and work orders with CDMOs and CROs, following internal procedures. • Oversee development and execution of integrated project plans, including timelines, budgets, and resource allocation across multiple workstreams. • Partner with Technical Operations, Legal, Finance, and external CDMOs/CROs to negotiate and finalize agreements, ensuring compliance and timely execution. • Monitor and manage project budgets, forecast resource needs, and provide financial oversight to support decision-making. • Proactively identify and mitigate risks, maintaining risk registers and implementing contingency strategies to ensure program success. • Deliver high-quality reporting and communication, including executive-level updates, dashboards, and presentations for governance forums. • Champion process improvements and best practices, driving operational efficiency and consistency across Technical Operations projects. • Other responsibilities may be assigned as required by management

• Provide QA oversight for the planning, execution, and reporting of clinical trials for biologic programs. • Ensure compliance with ICH-GCP, FDA 21 CFR Parts 50/54/56/312, EMA regulations, and other international clinical trial requirements. • Support audit readiness of investigator sites, Clinical Research Organizations (CROs), and internal clinical teams. • Participate in vendor qualification and ongoing oversight of CROs, ensuring compliance with contractual and regulatory obligations. • Review and manage deviations, CAPAs, and change controls associated with Clinical activities. • Ensure quality documentation is complete, accurate, and compliant with corporate standards and global regulations. • Support continuous improvement initiatives across Clinical QA functions. • Provide quality input into regulatory submissions, including INDs, BLAs/MAAs, and safety updates. • Serve as a QA liaison between Clinical Operations, Regulatory Affairs, and external partners (CROs, Safety Vendors). • Support training and awareness of GCP and corporate quality policies across internal teams and contractors. • Facilitate effective communication between internal stakeholders and global regulatory authorities during audits and inspections.

• Provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints. • Ensure compliance with global GMP, GCP, and pharmacovigilance requirements. • Collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation. • Safeguard patient safety, product quality, and regulatory compliance throughout clinical development. • Interact with all areas of Clinical, Regulatory Affairs, and Pharmacovigilance. • Engage with CROs and CMOs for regulatory inspections and audits.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Manager of Quality Assurance Product Complaints will provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints within a fully “virtual company” operating model. This role ensures that product complaints related to clinical drug substance and drug product are handled in compliance with global GMP, GCP, and pharmacovigilance requirements. - Operate as the primary QA owner for clinical product complaints. - Collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation. - Safeguard patient safety, product quality, and regulatory compliance throughout clinical development. Qualifications - Bachelor's degree and 7+ years of experience OR: - Master's degree and 4+ years of experience - PhD and 2+ years of experience may be considered - Hands-on experience with product complaints and investigations required - Strong understanding of cGMP, GCP, and global regulatory requirements related to clinical product complaint handling. - Proven experience managing complaint investigations, root cause analysis, CAPA development, and trending for clinical-stage products. - Demonstrated success supporting regulatory inspections and audits involving complaint systems and quality investigations. - Strong interpersonal and communication skills with the ability to influence cross-functional and external partners. - Experience with electronic quality management systems (e.g., Veeva) and deep understanding of data integrity standards. Requirements - Ability to travel up to 10%. Benefits - Base compensation range for this position is $120,300 to $222,600. - Eligible for a company bonus based on individual and company performance. - Long-term incentive compensation depending on the position's level or other company factors. - 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. - Time off pursuant to its sick time policy, flexible vacation policy, and parental leave policy. Company Description 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.

• Own and execute program and portfolio management strategy across Akero’s development organization • Serve as primary cross functional integrator, ensuring alignment between strategy, execution, governance and decision making across programs. • Partner with Development Therapeutic Area VPs and senior leaders to advance strategic priorities and ensure clear accountability, ownership, and decision rights. • Design, implement, and run Akero’s development governance model in alignment with the parent organization. • Establish and maintain decision-making frameworks, escalation pathways, and executive visibility into risks, trade-offs, dependencies, and outcomes. • Lead Akero Development governance meetings and ensure consistent alignment with parent company processes and expectations. • Collaborate with TechOps (CMC) to develop, gain approval, and execute on the project strategy in alignment with parent company • Lead cross-functional alignment across departments, proactively identifying and resolving risks, conflicts, and misalignments. • Oversee program timelines, integrated development plans, and delivery of key milestones across the portfolio. • Manage trade-offs and dependencies, escalating issues to senior leadership as needed to maintain progress and alignment. • Identify gaps in capabilities, training, and processes (e.g., GCP training), and partner with Quality to support compliance activities as needed. • Establish scalable systems, templates, tools, and best practices for program and portfolio management. • Own portfolio-level risk and issue management, ensuring mitigation strategies are proactively developed and executed. • Monitor program performance and intervene as needed to keep programs on track. • Partner with Finance and leadership on development budgets, forecasting, and resource allocation across the portfolio. • Build, mentor, and develop program management talent. • Organize and deploy project management support across functional areas and programs. • Foster a high-performing, accountable, and collaborative program management culture.

• Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation. • Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Clinical Program Manager. • Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track. • Under supervision may serve as the key operational contact for Akero studies aiding in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs. • Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required. • Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision. • Review of trip reports generated by CRO CRAs. • Maintains study timelines. • Coordinates review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies. • Provides regular study updates to the appropriate internal stakeholders. • Maintains internal Clinical Operations databases and document repositories. • Performs administrative duties in a timely manner as assigned.