Principal Scientist, Preclinical Programs

Principal Scientist, Preclinical Development
Natick, MA

Our client is an oncology-focused biotechnology company developing transformative cell-based immunotherapeutic products for the treatment of intractable solid tumors. They recently announced a Series A financing and plan to use this funding to progress the lead program. 

Responsibilities:

  • Responsible for managing a broad range of preclinical activities in support of
  • preIND and IND filing activities
  • Plan, design, and execute preclinical efficacy studies and safety studies
  • Proven ability to focus on multiple priorities to drive programs forward simultaneously
  • Identify, plan, coordinate and supervise study execution at external CROs
  • Author technical reports and regulatory filings for preINDs and INDs
  • Applies advanced technical writing skills to produce reports, presentations and documents
  • Communication of experimental plans and data to multiple cross-functional scientific teams

Qualifications:

  • PhD degree in biology, biochemical engineering, or relevant field with at least 5+ years of relevant industry experience
  • Strong technical understanding and experience in biopharmaceutical product lifecycle management
  • Proven experience with preparation of regulatory documents for preIND and IND filings
  • Previous experience with cell and/or gene therapy is required
  • Knowledge of regulatory guidelines for IND and BLA filing is a plus
  • Good writing and communication skills; ability to understand and communicate scientific information
  • Highly collaborative working style, and ability to adapt in a fast-paced environment
  • Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission