Clinical Program Manager – Global Study Lead

Akero Therapeutics

. Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study from start-up through closeout .

Posted 10/27/2026full-timeRemote • California • United StatesSenior💰 $152,700 - $267,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading global Phase 3 clinical studies, with a strong focus on CRO management, operational performance, and compliance with FDA/EMA regulations and ICH-GCP guidelines. Proven ability to manage study timelines, budgets, and cross-functional collaboration to ensure successful study execution.

Highest-signal resume keywords

Global Study LeadershipCRO ManagementClinical Trial ComplianceOperational Risk ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperiencePhase 3 Study ManagementStudy Timeline DevelopmentBudget ManagementOperational PlanningInspection ReadinessAudit ReadinessDocumentation OversightRegulatory ComplianceRisk Mitigation

Soft Skills

Problem-SolvingAttention to DetailCommunication SkillsCollaboration Skills

Certifications & Qualifications

BSBABNRN

Industry Keywords

Pharmaceutical IndustryBiotechnologyHealthcareICH GuidelinesGCP RequirementsFDA RegulationsEMA Regulations

About the role

Key responsibilities & impact

Serve as the Global Study Lead and primary Clinical Operations point of contact for a large, global Phase 3 study 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 identify, mitigate, escalate, and resolve 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, 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 regulations, ICH-GCP, SOPs, and study-specific plans
Manage or provide functional leadership to Clinical Operations personnel as required
Establish personnel goals, conduct interim reviews, and manage communication of Akero and Novo Nordisk policies and procedures

Requirements

What you’ll need

At least 8+ years of relevant clinical research experience and a BS, BA, or BN in a relevant scientific discipline, or 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
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
Ability to travel up to 25%

Benefits

Comp & perks

Company bonus based on individual and company performance
Long-term incentive compensation
Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
401(k) savings plan
Flexible spending accounts
Employee assistance program
Tuition reimbursement program
Group legal insurance
Critical illness insurance
Identity theft protection
Pet insurance
Auto/home insurance
Sick time policy
Flexible vacation policy
Parental leave policy