Teams at Prilenia

Lead GCP quality for Prilenia's clinical programs from startup through inspection readiness. Oversee CRO and vendor QA, eTMF quality, CAPA resolution, audits, and regulatory inspection responses. Provide GVP and GLP QA oversight, author SOPs, define quality metrics, build a fit-for-purpose QMS, mentor QA staff, and represent QA in cross-functional governance.

Lead global pharmacovigilance operations for clinical-stage biotechnology programs in Huntington’s disease and ALS. Develop safety strategy, operational documents, governance, SOPs, and core safety reports; manage vendors, CROs, budgets, KPIs, and compliance. Coordinate signal management, periodic reporting, risk mitigation, and regulatory interactions while partnering with Medical Safety, Regulatory Affairs, Quality Assurance, Biostatistics, and medical writing teams. Support clinical trials, expanded access programs, and preparation for commercialization.