Experience working in close collaboration with technical, regulatory, quality, clinical, project management, and supply chain functions, in a cGMP operational environmentExperience in leading and managing outsourced development and manufacturing efforts and associated operating budgetsExperience in preparing and defending regulatory documents including briefing books for regulatory meetingsDemonstrated track record of setting priorities, meeting timelines and motivating othersExcellent communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requiredPeriodic travel to manufacturing and other partner sites is required (approximately 10-20 % of time)The anticipated annualized base pay range for this full-time position is $183,000 - $223,000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Own DS program execution including development plans and timelinesCMO selection, RFP development, and technical evaluationOversight of tech transfer, scale-up, and GMP manufacturingContribute to and review CMC sections of regulatory filings and support health authority interactions.