Vice President
Clinical Development
Posted on 3/30/2023
INACTIVE
23andMe

501-1,000 employees

Personal genomics & biotechnology company
Company Overview
23andMe’s mission is to help people access, understand, and benefit from the human genome. The company has created the world’s largest crowdsourced platform for genetic research and is the only company with multiple FDA authorizations for genetic health risk reports. The company is also in development of discovery programs rooted in a diverse spectrum of human genetics to ultimately deliver reports and results from all spectrums of your DNA.
Locations
San Bruno, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Biology & Biotech
Requirements
  • MD degree or equivalent with postgraduate clinical training and prior clinical investigator experience; PhD or equivalent in a basic science field preferred
  • Substantial drug development industry experience including leading IND filings, pivotal phase 3 clinical trials, and NDA/BLA filings
  • Clinical research experience in oncology or immune-mediated disease with a proven track record of quality publications
  • Knowledge of applied research sufficient to understand how translational science enables the evolution into Clinical Development
  • Experience with large molecule candidate selection
  • Understanding of clinical evidence base guiding the use of molecular markers in patient selection
  • Working knowledge of genetic/genomic and bioinformatics technologies and their application to translational approaches
  • Ability to collaborate with internal and external multi-disciplinary research and development teams
  • Experience providing input into therapeutic target selection and validation
  • Outstanding organizational leader and mentor, with a track record of organization/team-building, talent attraction, and retention
  • Exceptional written and verbal communication capabilities
Responsibilities
  • Provide guidance and strategic input to project and development team leaders in areas such as developing target candidate and product profiles; selecting, validating and developing clinical biomarkers; understanding PK/PD relationships
  • Chair appropriate internal governance committees and make key decisions regarding clinical development strategy and prioritization
  • Provide clinical perspectives to preclinical sciences and strategically guide IND-enabling studies that will support clinical plans
  • Relate science/mechanisms of action to expected clinical profile in diverse therapeutic areas
  • Contribute to the utilization of human genetic information in clinical drug development
  • Define criteria for medical needs and selection of novel targets
  • Provide leadership to and support the success of new and existing collaborations/alliances with academic institutions and pharma/biotech companies
  • Work with senior leadership to help represent the company as a senior translational/medical spokesperson at appropriate scientific, medical, regulatory, business and other professional meetings
  • Direct a fit-for-purpose organization to inform and execute clinical development plans from clinical trial initiation through global regulatory approvals with concurrent predictive biomarkers as appropriate
  • Coach, mentor and manage employees, with varying levels of experience, for performance and scientific growth
  • Maintain compliance with all company policies and procedures
  • Perform other related duties as assigned