Clinical Program Manager – Global Study Lead

Job not on LinkedIn

🔥 3 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $152.7k - $267.3k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Akero Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Akero Therapeutics is a company pioneering novel therapies to transform the lives of people living with serious metabolic diseases. Their flagship program, Efruxifermin (EFX), is aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) and is currently undergoing multiple clinical trials. Akero is committed to advancing medicine in the field of metabolic diseases and has a strong focus on research, development, and clinical studies.

📋 Description

• 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

• 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

• 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