Associate Director, Analytical Development

Ardelyx is seeking an Associate Director, Analytical Development to lead the execution of small molecule analytical activities across clinical and commercial programs.

Requirements

• B.S. in chemistry or related discipline
• 9+ years of industry or equivalent experience
• Demonstrated experience in analytical method development and validation as well as associated regulatory requirements
• Experience working in close collaboration with technical, regulatory, quality assurance, project management, and supply chain functions in a cGMP operational environment
• Experience in managing outsourced Analytical Development activities
• Experience in preparing regulatory documents including briefing books for regulatory meetings, INDs, and NDAs
• Excellent communication skills and the ability to present to internal and external audiences
• Strong understanding of cGMP requirements and quality systems related to analytical development activities

Benefits

• 401(k) plan with generous employer match
• 12 weeks of paid parental leave
• Up to 12 weeks of living organ and bone marrow leave
• Equity incentive plans
• Health plans (medical, prescription drug, dental, and vision)
• Life insurance and disability
• Flexible time off
• Annual Winter Holiday shut down
• At least 11 paid holidays