Careers Data Science Gene Therapy Oncology Physicians West Coast

Sr. Director/VP – Cell Therapy Discovery

Position Overview:

The Sr. Director of Cell Therapy Development will be responsible for establishing therapeutic product requirements and develop IND-enabling strategies for our Drug Discovery group. The Sr. Director of Cell Therapy Development will develop, plan and implement product requirements to inform clinical programs for T cell receptor based cell therapies plus any potential future drug modalities to be developed. S/he will establish product efficacy and safety specifications. In the near-term, this role will focus on informing robust TCR data packages for IND submissions and IND-enabling clinical trials.

This key role within R&D will guide the cellular therapy product development strategy and successfully enable us to achieve its Drug Discovery clinical development goals.

Job Responsibilities:

  • Lead IND-enabling strategy and establish TCR-based cellular therapy development plans. 
  • Inform clinical Target Product Profile (TPP) and develop IND-enabling TCR data packages. 
  • Support R&D efforts to ensure the creation of comprehensive product development plans. 
  • Support communications to fulfill regulatory authority requirements and address inquiries (e.g. Pre-IND meetings, IND questions and answers). 
  • Lead the development of product characterization; maintain relevant requisite product controls. 
  • Develop reports to support regulatory submissions/filings. 
  • Track and report any significant changes to the TCR discovery process / methods that may require amendments to regulatory materials or impact future manufacturing process and product development. 
  • Lead efforts to inform framework for real-time, patient-specific TCR screening, including immune monitoring during clinical trials. 
  • Provide timely product development requirements that inform new product/clinical needs. 
  • Write and implement development protocols, review and interpret data.

Experience and Skills:

  • Advanced degree in Life Sciences: PhD, MD, or MD PhD. 
  • Strong background and experience in biologics product development. 
  • Experience in cellular immunology/biology and cellular therapy product development. 
  • >5 years of experience leading biologics product development. 
  • Demonstrated understanding of IND-enabling product requirements and product launch. 
  • Ability to work in a matrix environment and leverage cross-functional resources. 
  • Ability to interact strategically with drug discovery partners to inform product requirements. 
  • Ability to function autonomously and drive strategic decisions. 
  • Team leader with the ability to work and manage others. 
  • Ability to work effectively with senior-level stakeholders, internally and externally. 
  • Strong communication and interpersonal skills and good judgment. 
  • Independent strategic thinker with strong ability to solve complex problems. 
  • Excited about an early stage company environment and driven to make a difference.