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Director, Clinical Program Management

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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 to hire a Director, Clinical Program Management with broad vaccine experience for our Clinical, Regulatory and Medical Affairs Team (hereafter called ‘Clinical’). This position will be on the Clinical leadership team, reporting to the CMO, and play a key role in supporting our composite Clinical functions including Clinical Development, Clinical Operations, Regulatory, Medical Affairs & Policy and Bioanalytical.  The successful candidate will also interface with Icosavax cross-functional teams and management, and with our CRO/vendors for vaccine clinical development, bioanalytical, medical affairs/epidemiology/policy, and pharmacovigilance support. In addition, the successful candidate will support interactions with key external partners and stakeholders.                                                                                                                                         
The successful candidate will be highly self-motivated, productive, a quick learner, and creative. They will be comfortable partnering with diverse 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 Clinical team and partnering with employees at all levels of the organization. They will enjoy leading function specific teams as well as supporting fast paced vaccine development program 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.
JOB DUTIES: 
Manage Clinical team operations working in close partnership with the CMO and other members of the Clinical leadership. Coordinate with cross functional leaders, the Global Program Management (GPM) team, and other Icosavax colleagues.
Manage key CRO/vendor relationships, ensuring appropriately scoped work products and timely, on-budget, execution of scoped activities. Develop and maintain, in collaboration with our CRO partners, high-quality, integrated project plans, that align with overall program strategy.
Work closely with Finance and Legal teams and function to develop program-level Clinical budgets, identify appropriate budgeted activities to proposed scopes of work, track actual spend against budget, and flag expected future budget variances during reforecast periods.
Select and implement systems/tools to optimize clinical trial planning.
In support of the Clinical Operations group, prepare agendas and meeting minutes, record action items and decisions in official log, and follow up with staff and partners on action items/next steps. Moderate effective meetings.
Track and support effective and consistent execution of program priorities. Leverage strong program and organizational knowledge, leadership and facilitation skills to optimize functional team meetings and may serve as a functional representative to the Global Program Teams as assigned.
Work collaboratively to coordinate, influence and advise strategic and operational efforts to ensure alignment and timely execution of projects as assigned. Recommend strategies for improved program oversight and achievement of corporate goals.
Deliver project/activity kick-off presentations to review scope, roles and responsibilities, milestones and timeline, budget, communication flow, and key risks for execution.
Lead initiatives to gather stakeholder needs and buy-in for process improvement and operational integration.
Prepare standard reporting tools and templates for managing scope, budget, timeline, and resources for integrated projects with international partners. Create strategic flow charts to illustrate processes, flow of information, and decision points.
Maintain official project archives for Clinical function. Draft functional SOPs and templates for corporate use and to allow for consistency.
Oversee project and clinical risk management including defining, analyzing, planning responses, and monitoring and controlling risks.
Serve as the central integrator for regulatory, medical writing, bioanalytical methods, clinical operations, and biostats/data management, and link to CMC, nonclinical, and QA functional areas.
Engage with vendors, KOLs, and expert consultants to prepare draft contractual agreements in support of vaccine product development programs.
Help track clinical resource availability for pipeline opportunities and upcoming projects.
 
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 
BS required, advanced degree in related scientific field preferred.
12+ years of industry experience with 5+ years of program management experience in a clinical and cross-functional development capacity in the pharmaceutical/biotech industry.
Experience in biologics/vaccines is required.
Strong project management skills and ability to set and drive strategy and timelines.
Experience with Smartsheet or other project management tools (e.g., MS Project) required.
Project Management Professional (PMP) certification preferred.  
Proficiency with contracts and purchase order tracking.
Drug development knowledge with understanding and knowledge of the required Clinical functions with a preference for vaccines development experience.
Strong working knowledge with Regulatory and Clinical timelines, and of Regulatory interactions.
Proficiency with standard project management, virtual communication, and cloud- based documentation tools. Ability to create integrated timelines (including MS Project Gantt charts and visual timelines using MS PowerPoint Timeline). Ability to create forms in MS Excel with drop-down lists and conditional formatting.
Know how to plan and work across functional areas and incorporates milestones and critical pathways in the integrated timelines. Strong understanding of functional group responsibilities.
Investigational Product quantity and release planning for clinical trials.
Experience designing and setting up a Project Management Office (PMO) from the foundation to execution is desirable.
 
PHYSICAL DEMANDS: 
Manual dexterity required to operate office equipment (i.e., computers, phones, etc.).   
OTHER:
Location: Remote USA, Seattle area preferred.
Must be eligible to work in the USA.   
May require 10-20% offsite travel.
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.
The salary range for this position is $157,000 – $200,000 per year; the base salary will be determined based on knowledge, skills, education, experience relevant to the role and location. This role is also eligible for bonus and equity compensation. 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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