Regulatory

TCR² Therapeutics Inc. is an immuno-oncology company developing novel cancer therapies that unleash the full signaling power of complete T cell receptors (TCR). TCR² has developed a unique proprietary TRuC™ platform which can reprogram the natural TCR complex to recognize specific antigens found on tumors where they elicit rapid killing of cancer cells. The company has demonstrated activity against both hematological and solid tumor targets in preclinical models and believes its TRuC™-reprogrammed T cells will serve as the engine for important therapies.  TCR² was founded by MPM Capital and has scientific operations in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories around the world.

TCR² Therapeutics is building a clinical development team and is seeking talented and independent candidates to execute its clinical studies.  The successful candidate will ensure TCR² Therapeutics’ clinical trial(s) are managed to the highest quality to ensure safety and effectiveness of TCR² Therapeutics’ products in adherence with regulations. The position is an excellent opportunity for career development as TCR² Therapeutics is in the midst of building out the infrastructure to support an innovative clinical pipeline and the candidate will have the opportunity to help shape the future of the organization.

Responsibilities:

  • Propose and design well-informed regulatory strategies for the US and EU

  • Represent Regulatory Affairs on project subteams, especially Clinical and Nonclinical, and provide regulatory guidance to project teams (e.g., protocol reviews, report reviews, development plans)

  • Assist in the preparation for regulatory agency meetings (e.g., Pre-IND, End-of-Phase 2, Type C, Pre-NDA/MAA/NDS)

  • Lead the preparation of regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages

  • Write regulatory documents to support regulatory submissions

  • Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies

  • Coordinate with selected regulatory CROs for submission of high-quality documents to support Rest-of-World submissions

  • Establish and maintain ClinicalTrials.gov postings for supported studies

  • Establish relevant processes and procedures to support the Regulatory Affairs function activities

  • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements

  • Ensure compliance with regulatory requirements

Requirements:

  • Bachelor's degree in life sciences required; advanced degree preferred

  • Minimum of 8 years pharmaceutical industry experience with a minimum of 5 years in Regulatory Affairs

  • Experience with cell therapy products (preferably engineered adoptive cell therapies)

  • Evidence of successful submissions to FDA (e.g., INDs, briefing packages)

  • Demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages, orphan drug designation applications, pediatric plans)

  • Knowledge of FDA and ICH regulations and guidelines a must

  • Knowledge of EU and Health Canada regulations and guidelines desirable

  • Knowledge of drug development

  • Excellent written and oral communication skills

  • Excellent interpersonal skills

  • Strong project management skills and drive for excellence

  • Office-based position in Cambridge, MA

Interested candidates should send their resume to careers@tcr2.com