Job Title: Sr. Director - Preclinical Development

Reports To (Title): CSO

Function: Preclinical

Written By: D. Holtzman

Date Written: Aug 2019

Effective Date: 

 

OBJECTIVES: 

  1. Support preclinical research efforts to develop vaccine candidates through project management of external contract research organizations (CROs) and academic collaborators.

  2. Develop, review and implement (with CROs and academic collaborators) research protocols for the assessment of structure, immunogenicity, safety and efficacy of candidate molecules through in vitro and in vivo studies, including GLP nonclinical, to advance vaccine development.

  3. Provide support for scientific presentations at Board and external meetings through the analysis and formatting of data.

  4. Draft and support integration of nonclinical elements of regulatory filings.

ACCOUNTABILITIES: 

  1. Responsible for regular engagement with CROs and academic collaborators to ensure progress on preclinical research activities, including protein expression, initial characterization and animal testing of potential candidate molecules.

  2. Responsible for providing technical support and expertise to research, development and program management personnel both internally and with collaborators/CMO to ensure study designs are appropriate and effective.

  3. Responsible for development, negotiation and oversight of contracts to CROs to support Icosavax pipeline programs

  4. Responsible for overseeing collection and interpretation of data for biomarker and biological characterization assays, including cell-based, multiplexed protein assays, polymerase chain reaction, and flow cytometry methods.

  5. Responsible for review of nonclinical research reports from vendors and academic collaborators.

  6. Responsible for processing data and developing materials for internal and external presentations to help communicate the status of preclinical activities performed either internally or externally under contract and/or sponsored research agreements.

  7. Other duties as needed.

 

 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

  • Advanced degree (MS and/or Ph.D.) in molecular biology, biochemistry, or closely related field, or equivalent experience applicable to the job responsibilities

  • Experience with advancing preclinical candidates to regulatory filings required; expertise with vaccines, infectious disease and toxicology a plus  

  • 10-15 years of significant applicable industry experience – direct experience with vaccines and/or infectious diseases strongly preferred

  • Expertise in GLP studies and familiarity with documentation required to support product development.

  • Excellent self-management, organizational, and verbal/written communication skills.

  • Demonstrated proficiency in data handling, analysis, and presentation (both verbal and written), including Excel and PowerPoint

 

PHYSICAL DEMANDS: 

 

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

 

TRAVEL REQUIREMENTS:

 

  • Location is Seattle Washington, USA.

  • Willingness to travel to various meetings or collaborator sites as needed, including overnight trips. Some international travel may be required.

  • Requires approximately 20-25% travel.

Icosavax, Inc.

2815 Eastlake Ave E, Suite 300

Seattle, WA 98102

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