Associate Director, Analytical Development

Ardelyx•Waltham, MA

1d•Hybrid

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. We are seeking an experienced and strategic Associate Director, Analytical Development, to lead the execution of small molecule analytical activities across clinical and commercial programs. This role partners closely with the Director to shape and implement analytical strategies while driving day-to-day execution through external partners. The Associate Director provides technical leadership across analytical activities, ensures alignment with regulatory expectations, and contributes to the progression of programs from early development through commercialization. This role collaborates cross-functionally with CMC, Quality, Regulatory, and external partners to ensure timely and high-quality deliverables. This is a hybrid role (2-3 days in office) at our Waltham, MA headquarters.

Requirements

B.S. in chemistry or related discipline with 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

Responsibilities

Lead execution of phase-appropriate analytical development strategies in alignment with Director guidance for external partners (CMOs/CROs), ensuring quality, timelines, and alignment with program goals
Oversee analytical method development, qualification, validation, and transfer activities to support clinical and commercial programs
Partner cross-functionally and external analytical partners to advance programs, escalating risks and proposing solutions proactively
Provide technical review and guidance on analytical data, protocols, and reports to ensure scientific rigor and compliance
Participate in the author and review of analytical sections of regulatory submissions (INDs, NDAs) in collaboration with senior leadership
Represent the Analytical Development function on various cross-functional project teams including internal project teams as well as third-party analytical and manufacturing teams
Ensure analytical activities are aligned with regulatory expectations and internal quality standards
Contribute to continuous improvement initiatives, including processes, workflows, and vendor management practices