Repertoire Immune Medicines is a clinical-stage biotechnology company working to unlock and direct the remarkable power of the human immune system to prevent or treat cancer, as well as autoimmune and infectious disease. Backed by SoftBank VF.
About the role
Repertoire Immune Medicines is seeking an experienced Senior Director of Regulatory Affairs to serve as the company’s first internal Regulatory Affairs hire and senior regulatory leader for its clinical-stage oncology programs. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Serve as the internal Regulatory Lead for Repertoire’s clinical-stage oncology programs, developing and executing global regulatory strategy from Phase 1/2 development through registrational planning
- Lead regulatory strategy and execution for INDs, CTAs, amendments, and other submissions supporting new and ongoing clinical studies
- Serve as the accountable regulatory lead for all components of Repertoire’s development programs, including any associated assays, biomarkers, diagnostics, or devices, as applicable
- Partner cross-functionally with Clinical Development, Clinical Operations, CMC, and Quality to embed regulatory strategy into development plans and program decisions
- Advise on clinical protocols, development plans, CMC changes and comparability, IND/IMPD content, product stability, and other issues arising during clinical development
- Anticipate regulatory risks and opportunities, lead resolution of critical regulatory issues, and develop practical, well-vetted mitigation strategies
More about this role
Repertoire Immune Medicines is a clinical-stage biotechnology company harnessing the power of the human immune system to develop transformative therapies for cancer and autoimmune disease. Using its proprietary DECODE™ platform—which maps the immune synapse between T cell receptors (TCRs) and their antigen targets—Repertoire translates unique biological insights into potent and targeted off-the-shelf immune medicines. The company integrates deep protein engineering expertise with artificial intelligence, powered by a proprietary DECODE database of over one billion TCR-antigen interactions, to accelerate discovery and optimize drug candidates.
From its sites in Watertown, Massachusetts and Zurich, Switzerland, Repertoire is advancing a pipeline of T cell-targeted immunotherapies with the potential to address a broad range of cancers and autoimmune disorders. The company’s lead oncology program, RPTR-1-201, a TCR bispecific, is being evaluated in an ongoing Phase 1/2 clinical trial in the U.S. and Europe across multiple solid tumor indications. RPTR-1-201 has received FDA Fast Track designation for advanced triple-negative breast cancer. Repertoire plans to advance additional TCR...
Read the full posting on Repertoire Immune Medicines's site ↗
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