Teams at Lindus Therapeutics

Lead regulatory strategy and agency interactions for an in‑licensed clinical-stage biopharma portfolio. Own pathway selection, endpoints, and filings (INDs, NDA/BLA involvement), manage external experts and KOLs, perform regulatory diligence, and advise executives to de-risk timelines and support exit readiness.

Lead CMC across an in-licensed clinical-stage portfolio: manage drug substance/product, analytics, stability, GMP quality and QP release; select and oversee CDMOs and testing labs; author/own Module 3 CMC for regulatory filings; de-risk inherited CMC packages; build consultant/KOL networks; ensure programs remain on time and budget to enable rapid clinical development.