Teams at Lindus Therapeutics

Leads statistical strategy across a clinical-stage biopharma portfolio while remaining hands-on across protocols, analyses, database lock, and clinical study reports. Represents biostatistics with regulators, oversees statistical programming and medical writing, evaluates external clinical data for licensing, and guides adaptive trial design, submissions, CRO partnerships, and AI/ML workflow innovation. Builds and leads the biostatistics function as the portfolio expands.

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.

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.