Clinical Operations Manager

Icosavax, Inc. (NASDAQ: ICVX) is a publicly traded biopharmaceutical company leveraging its innovative VLP platform technology to develop vaccines against infectious diseases, with an initial focus on life-threatening respiratory diseases. Icosavax’s VLP platform technology is designed to enable multivalent, particle-based display of complex viral antigens, which it believes will induce broad, robust, and durable protection against the specific viruses targeted. Icosavax’s pipeline includes vaccine candidates targeting respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based in Seattle, Icosavax was formed in 2017 to advance the breakthrough VLP technology from the Institute for Protein Design at the University of Washington with the goal to discover, develop, and commercialize vaccines against infectious diseases.
Icosavax seeks an experienced Clinical Operations Manager to lead and manage specified clinical projects while adhering to budget, scope, and timeline requirements and applicable regulations.
Manages Sponsor’s day-to-day study-related activities to meet defined study timelines; works closely with internal and external team members to ensure IVX compliance with applicable regulations and FDA/EMA/ICH guidelines
Responsible for the set-up and oversight of a specified clinical project from study planning, execution, data analysis through close-out
Actively participates in CRO meetings, including regular CRO study team meetings and protocol training, and provides Sponsor oversight
Responsible for reviewing the content and adhering to CRO study operational plans (e.g., project management plans, communication plans, quality plans, safety plans, risk management plan, monitoring plan, communication plan, etc.)
Responsible for the oversight of the development of study-related documents such as informed consent, case report forms, electronic diaries, user acceptance testing for various databases, etc.
Contributes to the development of RFPs and participates in selection of CROs/vendors; manages CROs/vendors activities to ensure adherence to budget, deliverables, performance/quality, and timelines; may train CROs/vendors and study sites on study requirements
Tracks study progress and proactively escalates project-related issues to key internal stakeholders as needed, including those related to time, budget, and quality. Ensures timely resolution of these issues and provides feedback to management.
Ensures the ongoing compilation and reconciliation of the Trial Master File is “audit-ready” at all times. Ensures that any audit observations are addressed appropriately and in a timely manner
Acts as a liaison between functional areas for project-related matters
Bachelor’s degree in a scientific/healthcare or business/finance discipline is required. A Master’s degree is preferred
5+ years of industry experience (biotech/pharma) with at least 2 years as the lead clinical project manager is required; 2 years monitoring experience strongly preferred
Proven experience in managing and executing US and/or global trials from start-up to database-lock, as well as solid experience in management of CROs/vendors to quality, timelines, and budget
Prior direct experience managing vaccine trials strongly preferred
Strong understanding of ICH, GCP and relevant regulatory requirements, guidance, and guidelines. Understanding of inspection readiness, audit preparation and clinical quality assurance strongly preferred.
Strong operational and management skills with attention to detail; solid problem solving and analytical skills; identifies issues and problems and suggests solutions
Proficiency in verbal and written presentations (including Microsoft Outlook, Word, Excel, and PowerPoint)
Demonstrated ability to deal with competing priorities, work independently in a fast paced, cross functional, start-up environment
Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
Location: Remote (or on-site in Seattle)
Must be eligible to work in the USA
To reduce the presence and severity of COVID-19 cases in the workplace and in our communities, Icosavax requires all newly hired employees to be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state and local law.
Travel demands: 10-20% expected to various meetings or clinical sites. International travel may be required. requirements
The salary range for this position is $130,000 – 150,000 per year; the base salary will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered health insurance (medical, dental, vision), health savings account with company contribution, flexible spending account, life insurance, short- and long-term disability, employee stock purchase plan, 401(K) plan with company contribution, vacation, sick and safe time, company holidays and floating holidays.

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