[Hiring] Clinical Program Manager @Akero Therapeutics

Role Description

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
• Interacts with all areas of Clinical and clinical within Novo Nordisk
• Engages with team members at the IC through Vice President level
• Requires experience interacting with senior level positions in each of these departments
• Externally engages with CROs at the Scientist level

Essential Functions:

• Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study, providing end-to-end operational leadership from start-up through closeout.
• Lead global study planning and execution, including start-up, enrollment, site management, and ongoing study conduct through CRO partners.
• Provide oversight of CROs and external vendors, ensuring alignment on priorities, timelines, deliverables, quality, risks, and study performance.
• Partner with cross-functional stakeholders to drive successful study execution and lead the identification, mitigation, escalation, and resolution of operational risks and issues.
• Develop and manage study timelines, enrollment projections, operational plans, budgets, and key study metrics.
• Provide regular updates to internal stakeholders and senior leadership on study progress, key risks, mitigation plans, and decisions.
• Review key study documents and oversee monitoring activities, study quality, and maintenance of study documentation and systems.
• Support inspection and audit readiness and ensure compliance with applicable regulations, ICH-GCP, SOPs, and study-specific plans.
• As required, manage or provide functional leadership to Clinical Operations personnel supporting the study.

Physical Requirements:

• Ability to travel up to 25%.

Development of People:

• Ensure that reporting personnel have individual goals, with annual goals and measurements that are consistent with the priorities of the business.
• Hold interim reviews 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)

Requirements

• 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.

Benefits

• Base compensation range for this position is $152,700 to $267,300.
• 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.
• Participation in 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.