The Vice President of Quality will lead the company's quality function through clinical development, regulatory approval, and commercial launch. They are responsible for designing and scaling a phase-appropriate Quality Management System and ensuring global GxP compliance.
The Director will lead global drug safety and pharmacovigilance strategy, overseeing signal detection, risk management, and regulatory interactions for development programs. They will also build core safety infrastructure and represent the department in cross-functional governance forums.
Provide strategic statistical leadership across clinical development programs, including study design, analysis, and regulatory submissions. Partner with cross-functional teams to ensure scientific rigor and oversee external biostatistics and programming partners.
The Director will lead global regulatory strategy for development programs, including managing health authority interactions and marketing application readiness. They will also provide strategic guidance to cross-functional teams and build the regulatory infrastructure for the organization.
Lead the global medical affairs strategy and scientific narrative for a late-stage oncology asset. Partner with cross-functional teams to drive evidence generation, KOL engagement, and successful product launch execution.
