Job Title: Director / Senior Director, Clinical Operations 

Reports To (Title): CMO

Function: Clinical Development 

Written By: N. Kanesa-thasan

Date Written: September 2019

Effective Date: 

Icosavax is a young vaccine start-up company with an exciting virus-like particle platform technology. We are seeking an experienced clinical operations professional to progress and shape our clinical development program. This role will be key to the company’s success. 

OBJECTIVES: 

  1. Lead the planning, execution and oversight of first-in-human clinical trials with our lead candidate Respiratory Syncytial Virus (RSV) vaccine 

  2. Help to develop and implement Clinical Operations processes and procedures for a growing Clinical department 

  3. Adhere to target budget, timelines and study milestones as agreed with CMO 

  4. Provide oversight and promote quality in trial execution with investigators, study sites, Contract Research Organizations (CROs) and other third-party vendors supporting Icosavax trials 

  5. Identify, mitigate and communicate study risks to the RSV program team 

ACCOUNTABILITIES: 

  1. Participate in authoring Investigational New Drug (IND) and Clinical Trial Application
    (CTA) documents including study protocols, Investigator Brochure, Informed Consent Forms, Case Report Forms, Clinical Study Reports, and pharmacy, laboratory and other study related manuals.

  2. In partnership with CMO, regulatory affairs and quality, participates in global IND/CTA submissions as well as oversight of additional resources needed (including for audits, Qualified Person readiness, document translations, etc.).

  3. Representing clinical operations on the RSV program team, provides overall status updates, escalates issues and presents on risk mitigation strategies to the cross-functional Development team.

  4. Lead in the selection of CROs and other vendors in support of Icosavax-sponsored clinical trials.

  5. Ensures appropriate oversight of CROs and other external vendors, including assessment of performance (quality, cost and time) against contractual obligations

  6. Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.

  7. Develops close relationships with Investigators and clinical site staff as appropriate to ensure optimal Sponsor-study site relationships

  8. Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress.

  9. Coordinate study team meetings. Develop and ensure execution of activities outlined in study plans (including recruitment, data management, safety management, and communication plans)

  10. Partners with Clinical Supply and Technical Operations to oversee drug supply and handling of the investigational drug product. Participate in long range supply planning for trials within the RSV vaccine program

  11. Performs quality assurance checks (e.g. reviewing protocols for operational effectiveness, monitoring trip reports, conducting co-monitoring visits at clinical sites as needed, reviewing data listings or profiles at specified time points) 1

  12. Manage assigned clinical study budget(s) through review of study-level scopes of work, invoices, and change orders in accordance with the evolving needs of the study

  13. Drives quality efforts to proactively identify and manage risks to trial quality and ensure inspection readiness. Apply appropriate corrective and preventative actions as needed.

 

 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

  • Bachelor’s degree in a scientific/healthcare or business/finance discipline is required. An advanced degree (Master’s degree or above) is preferred. 

  • At least 6+ years in clinical operations or drug development experience in a CRO or Pharmaceutical Company, with proven experience in the oversight of the operational aspects of all stages of clinical studies (emphasis on Phase 1 through P2b trials). 2-4+ years clinical project management experience with complex clinical studies preferred. 

  • Prior experience managing vaccine trials required (global clinical trials preferred). Experience and familiarity with operating clinical trials outside the US, and/or with older adult populations, will be favorably considered. 

  • Strong regulatory knowledge of Code of Federal Regulations and European Union Directives, including Good Clinical Practices (GCPs) and International Council on Harmonization Guidelines 

  • Exceptional verbal/written communication and organizational skills and ability to deal with competing priorities. Strong reasoning and problem-solving ability as well as the ability to work independently in a fast paced, cross-functional, start-up environment 

  • Ability and willingness to travel (15-20% of the time) to various meetings or client sites, including overnight trips. International travel may be required. 

  • Demonstrated proficiency in data capture, cleaning and analysis, and in verbal and written presentations (including Microsoft Word, Excel and Powerpoint). 

 

PHYSICAL DEMANDS: 

 

  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).   

 

TRAVEL REQUIREMENTS:

 

  • Preferred location is Seattle Washington, USA.

Icosavax, Inc.

2815 Eastlake Ave E, Suite 300

Seattle, WA 98102

  • White Twitter Icon
  • White Facebook Icon
  • White LinkedIn Icon
SEND US A MESSAGE

© 2019 Icosavax, Inc. All rights reserved.