Sr. Clinical Trial Manager

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 Sr. CTM is a key member of Clinical Operations and will closely partner with the Clinical Program Manager and the EMEA Clinical Trial Manager in the oversight and conduct of the EMEA region Job Responsibilities Assists 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 in conjunction with the EMEA CTM. Oversees and assists the EMEA CTM with the following: day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with EMEA sites. Oversees and assists the EMEA CTM in timely completion of deliverables and proper issue resolution/escalation and communicates/escalates to Clinical Program Manager. Leads EMEA regional regulatory submission strategies and package review in collaboration with Regulatory Affairs and other operational team members (e.g., CTA, EC/RA submissions, responses, and approvals). 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 in EMEA region. 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 and reviews internal Clinical Operations databases and document repositories (including the study TMF). Performs administrative duties in a timely manner as assigned. Mentors junior team members and contributes to operational process improvements. 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 and reviews internal Clinical Operations databases and document repositories (including the study TMF). Performs administrative duties in a timely manner as assigned. Mentors junior team members and contributes to operational process improvements. Physical Requirements Ability to travel up to 25%. Qualifications At least 6+ years of relevant experience and a BS or BA in a relevant scientific discipline OR At least 6+ years of experience and an RN (2 or 3 year certificate) Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent Experience as a regional lead for ex-US (Europe preferred) required. 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 (strong knowledge of Excel preferred) Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision High energy level, personal productivity, creativity and commitment. Team-player desiring 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). Strong knowledge of EMEA regulatory environment, submission processes, and timelines (e.g., EU CTR, MHRA, ANSM, etc.). Prior work in a small to mid-sized biotech or sponsor-side environment preferred Relevant Experience: Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent Experience as the regional lead for Europe, United States, and/or India. 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 Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision High energy level, personal productivity, creativity and commitment. Team-player desiring 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 $120,300 to $ 222,600. 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 October, 9 2026. The Company may however extend this time-period, in which case the posting will remain available on our careers website at 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.