The Associate Director will lead quantitative sciences by designing and interpreting QSP, PopPK, and exposure-response analyses to inform dose selection and lifecycle strategies. They will also collaborate with cross-functional teams to support regulatory submissions and provide strategic recommendations for autoimmune and neuromuscular disease programs.
The Associate Director will oversee the strategic direction, operational planning, and execution of global clinical trials while managing internal and external resources. They will collaborate with cross-functional teams to ensure trial compliance, budget adherence, and efficient patient recruitment.
The Associate Director will lead competitive intelligence and develop market insights to support the commercialization of autoimmune and rare disease programs. They will also build fact-based forecasting models and collaborate with cross-functional teams to shape development and portfolio strategy.
The Senior Clinical Data Manager will oversee all clinical data management activities from study start-up through database lock and closeout. They are responsible for managing relationships with CROs and vendors while ensuring data quality and regulatory compliance across the clinical portfolio.
Manage and track inter-disciplinary drug development programs by coordinating with scientific leadership and strategic partners. Develop integrated program plans, manage budgets, and implement mitigation plans to ensure alignment with corporate goals.
Lead the operational oversight of clinical external manufacturing for monoclonal antibodies and biotherapeutics. Manage the transition from drug substance to drug product, focusing on formulation optimization and the development of prefilled syringe delivery systems.
