Top Tech Jobs & Startup Jobs in Denver & Boulder, CO

The Sr. Manager, Biostatistics leads statistical activities for clinical studies, ensuring quality deliverables and compliance with regulatory standards while collaborating cross-functionally and with external partners.

The IT GxP Business Partner will manage GxP systems strategy, optimize business processes, lead system implementation, ensure regulatory compliance, and support cross-functional collaboration.

The Sr. Director of Business Development will drive Kyverna's growth strategy through strategic partnerships, licensing, and collaboration in the biopharmaceutical sector.

Lead SEC reporting and technical accounting for a clinical-stage biotech, ensuring U.S. GAAP and SOX compliance, preparing SEC filings (10-K/10-Q/8-K/etc.), supporting revenue recognition for commercialization, managing equity accounting and audits, and partnering cross-functionally on accounting policies and reporting processes.

Lead cross-functional CMC program management for a cell therapy candidate through late‑stage development and licensure. Develop integrated program plans, manage timelines, budgets, CDMO partners, risks, governance, and stakeholder communications. Mentor direct reports and drive delivery of CMC deliverables for regulatory milestones.

The role involves providing legal counsel on commercial agreements, compliance, regulatory matters, and strategies for a biotech company. Responsibilities include reviewing contracts, advising on healthcare compliance, and offering legal guidance for commercialization efforts.

Lead global safety and pharmacovigilance strategy for cell therapy programs, oversee PV operations (case processing, signal detection, reporting), ensure regulatory compliance, manage vendors and safety databases, support regulatory submissions and inspections, and drive benefit-risk assessments and post-marketing safety planning.