Arvinas

Operations

• Leadership of the Technical Operations group which incorporates exploratory pharmaceutics, API, DP and Analytical Development, supply chain planning, and CMC authoring.
• Ensuring product supply from pre-clinical development through clinical to commercialization.
• Providing strategic direction and planning of the technical development and manufacturing of clinical/commercial products with attention to quality, robust and reliable supply, cost-effectiveness and efficient scaling.
• Continuing a Technical Operations approach that establishes fast-to-clinic and fast-to-commercial as primary objectives in support of the Arvinas pipeline.
• Responsible for establishing and managing the relationships with contract manufacturers, to assure that commercial and clinical production needs are met cost-effectively and in compliance with all GMP regulations and regulatory standards.
• Establishing partnerships with Discovery, Clinical, Quality, Regulatory and Commercial to ensure a rapid and successful progression of assets to the commercial market.
• Developing and managing annual expense budgets with accurate forecasting based on strategic objectives and prudent decisions regarding expenditures.
• Interfacing with senior management to reach decisions that provide best opportunity for organizational success.
• Leading the compilation and review of technical sections for Module 2/3 in INDs, IMPDs, NDAs, and MAAs.
• Acting as a key executive interface with FDA and EMA for quality sections in INDs, NDAs, IMPDs, and MAAs.
• Building a high performing team ensuring that organizational depth is maintained for all key positions.

Vice President – Technical Operations