Senior Program Manager
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SUMMARY: Icosavax, Inc. is a start-up biotechnology company focused on developing potential “best-in-class” vaccines for respiratory diseases in older adults using a protein-based virus-like particle (VLP) vaccine platform. This VLP technology allows for stable, multivalent display of immunogens, driving a more robust immune response, and therefore should yield improved efficacy compared with conventional approaches. Icosavax has an experienced management team and has raised over $150M to date. Icosavax has two vaccine candidates expected to move into clinical studies in 2021 including a respiratory syncytial virus (RSV) vaccine and a SARS-CoV-2 vaccine. In addition, Icosavax is rapidly developing a broad pipeline of other vaccine candidates using their VLP platform technology. Our programs currently range from early discovery through IND enabling nonclinical/CMC activities, soon moving through to regulatory submissions and Phase 1 clinical studies. Icosavax conducts its development work in a semivirtual model, leveraging both internal laboratory facilities as well as partnering with many CROs, CDMOs, consultants and KOLs.
OBJECTIVE: Icosavax seeks to hire a Program Manager with biotech experience for our Global Program Management Team. This position will play a key role in leading Program Teams from discovery through regulatory submission and Phase 1 initiation and beyond, supporting the day-to-day development operations of key functional and cross-functional teams, interact closely with management, as well as partner closely with teams across the organization. The successful candidate will be highly self-motivated, productive, a quick learner, and creative. They will be comfortable partnering with diverse technical and drug development functions to manage timeline and budgetary risks and to drive strategic programmatic success. They will have excellent problem-solving skills as well as strong written and verbal communication skills. This position requires an independent strategic thinker motivated by performance excellence and team success, someone who can roll up their sleeves and assist where needed, working within a lean operations team and partnering with employees at all levels of the organization. They will enjoy leading fast paced vaccine development program teams as well as supporting function specific teams. The successful candidate will be a positive and enthusiastic team player, able to work with moderate guidance and take pride in the quality and timely delivery of their work.
• Manage Program Team operations working in close partnership with other members of the GPM team, functional leaders and colleagues
- Develop and maintain high-quality, integrated project plans, through regulatory submission, Phase 1 start and beyond, that align with overall program strategy and drive communication, scenario planning and decision-making o Facilitate communication across nonclinical, CMC, and clinical during candidate selection and hand-off from lab-scale generation to small-scale manufacturing at a CDMO
• Develop and implement stage appropriate processes, best practices and tools to increase efficiency and consistency of program team processes and deliverables: o Integrated timelines and associated Gantt charts, target product profiles, stage gate processes, etc.
• Drive program planning and management, including cross-functional resource planning and tracking
• Work closely with finance team and functions to develop program-level budgets, identify appropriate budgeted activities to proposed scopes of work, track actual spend against budget, and flag expected future budget variances during reforecast periods
• Leverage strong program and organizational knowledge, leadership and facilitation skills to optimize team meetings and facilitate effective governance and decision-making
• Track and support effective and consistent execution of program priorities
• Facilitate team alignment on key programmatic decisions and issue resolution • Drive program risk management via identification of key risks and facilitation of mitigation and contingency planning
• Support program teams and function teams as required with meeting organization, meeting notes, action item tracking and follow-up
• Work with functional teams to manage key vendor/CRO/CDMO relationships, ensuring appropriately scoped work products and timely, on-budget, execution of scoped activities.
• Work collaboratively to coordinate, influence and advise strategic and operational efforts to ensure alignment and timely execution of program
• Minimum of 5 years of multi-disciplinary experience in the pharmaceutical/biotech industry, with experience in cross-functional drug development, preferably biologics/vaccines
• 3 years of experience as a cross-functional program manager in the pharmaceutical / biotech industry
• Program/project management, IND-enabling activity planning and/or familiarity with nonclinical, Phase 1 through later clinical activities (vaccine preferred)
• Drug development knowledge with understanding and knowledge of the required component functions (discovery research, nonclinical, CMC, regulatory and clinical)
• Strong project management skills and ability to set and drive timelines
• Proficiency with Smartsheets or other Gantt tools
• BS required; advanced degree in related scientific field preferred
• Manual dexterity required to operate office equipment (i.e. computers, phones, etc.)
Location for this role is at the Icosavax headquarters in Seattle, Washington, USA.
Please send cover letter and resume to firstname.lastname@example.org
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Icosavax is dedicated to advancing vaccines against severe life-threatening respiratory diseases to protect our most at-risk populations.