Senior Director, Development Clinical Operations

BS/BA degree in science-related discipline; or, Advanced degree in related discipline; or, Certification in assigned area. 12+ years plus of related experience, contingent on education/training. Oncology and/or rare disease experience is preferred. Extensive clinical operations knowledge and cross-functional understanding of global clinical trial planning and execution. Experience with participating in and preparing for regulatory inspections. Experience developing trial plans including, site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management. Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally. Adept at addressing and solving challenges with complexity and ambiguity. Ability to communicate vertically and horizontally through multiple channels. Prior experience managing full-time and contract employees.

Partner with leadership and stakeholders to develop and implement operational strategy for the clinical portfolio. Translate asset strategy into operational plans, timelines, budgets and resource models. Oversee and ensure timely and high-quality execution of global clinical trials. Lead outsourcing strategy, vendor/CRO selection, negotiation, oversight and performance management. Forecast, plan and manage resource needs for current and pipeline programs. Lead, develop and inspire a high-performing clinical operations organization. Ensures compliance with GCP/ICH, FDA/EMA regulatory requirements and corporate standards. Proactively identify and manage operational risks and opportunities across the portfolio.