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.
- 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.