Clinical Program Manager - Regional & Vendor Oversight

Purpose:

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 Clinical Program Manager (CPM) is a key member of Clinical Operations and will closely partner with the Senior Director of Clinical Program Management. The CPM will serve as the Global Study Lead for a large, global Phase 3 clinical study within a Phase 3 program, with accountability for the operational planning, execution, oversight, and delivery of the study.

Relationships:

Reporting to the Senior Director, Clinical Program Management

The position will interact with all areas of Clinical. In addition, clinical within 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.  For CROs it will be at the Scientist level.

Essential Functions:

• Provide Clinical Operations oversight across assigned regions, CROs, and vendors within a large, global Phase 3 program, ensuring consistent execution against study plans, timelines, quality expectations, and regulatory requirements.
• Partner closely with Global Study Leads, regional teams, CROs, and vendors to monitor study performance, identify operational risks and trends, and drive timely resolution of issues.
• Provide oversight of regional study execution, including site start-up, enrollment, monitoring, site performance, and ongoing study conduct.
• Monitor CRO and vendor performance, study metrics, and operational trends; identify risks and gaps and drive timely mitigation, escalation, and corrective actions
• Analyze study metrics and operational trends across regions and vendors to identify areas requiring additional oversight, escalation, or mitigation.
• Support inspection and audit readiness activities, including assessment of study documentation, identification and remediation of gaps, and coordination of readiness activities with internal teams, CROs, vendors, and study sites.
• Ensure study activities and documentation comply with applicable regulations, ICH-GCP, SOPs, and study-specific plans.
• Partner with cross-functional stakeholders, including Clinical Research, Data Management, Biostatistics, Regulatory, and Quality, to support successful program execution.
• Provide regular updates on regional and vendor performance, key risks, and inspection readiness to Clinical Operations leadership and study teams.
• Contribute to key study documents and participate in CRO, vendor, and site oversight activities, including accompanied site visits, as appropriate.
• As required, manage or provide functional leadership to Clinical Operations personnel supporting the program.

Physical Requirements:

• Ability to travel up to 25%.

Development of People:

• Supervisory
• Ensure that reporting personnel have individual goals,, with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Manage the application and communication of all Akero and Novo Nordisk policies, procedures.

Qualifications:

• At least 8+ years of relevant clinical research experience and a BS, BA, BN in a relevant scientific discipline or
• At least 8+ years of clinical research experience and an RN (2 or 3 year certificate)
• Technical Requirements and Skills:
• At least 8+ years of clinical research experience and an RN (2 or 3 year certificate)
• Relevant clinical trial experience supporting large, global Phase 3 studies or programs within the pharmaceutical, biotechnology, or healthcare industry.
• MASH (formerly NASH), MASLD, and/or metabolic disease experience preferred.
• Demonstrated experience with regional study oversight, CRO/vendor management, and operational performance.
• Experience supporting clinical trial inspection and audit readiness, including identification and remediation of operational or documentation gaps.
• Strong operational, problem-solving, and risk management skills with exceptional attention to detail.
• Strong knowledge of FDA/EMA regulations, ICH guidelines, and GCP requirements.
• Excellent communication and collaboration skills with the ability to work effectively across global, cross-functional teams.

The base compensation range for this position is $152,700 to $ 267,300. 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 November 13, 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.