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Associate Director, Analytical Development Small Molecule

Ardelyx

Job Location:

Waltham, MA - USA

Monthly Salary: Not provided by the employer

Posted: 18 May 2026 (30+ days ago)

Application Deadline: 29 September 2026

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Description

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.

Position Summary:

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.

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

Qualifications:

B.S. in chemistry or related discipline with 9 years of industry or equivalent experience
Demonstrated small molecule 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
Periodic travel to manufacturing and other partner sites (approximately 10% of time)

The anticipated annualized base pay range for this full-time position is $183000 - $223000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees including a 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 and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.

We do not accept unsolicited resumes from search firms or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Companys career site without a valid signed search agreement signed by Companys authorized representative will be deemed the property of the company and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.

Required Experience:

Director

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