Clinical Supply Chain Contractor - 3 Months

Clinical Supply Chain Contractor

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.

This position is hybrid-based (2-3 days) out of our Newark, CA office.

We are seeking a highly motivated Clinical Supply Chain Contractor for a 3-month engagement supporting investigational drug supply activities for ongoing clinical trials. Reporting to the Associate Director, Supply Chain, this individual will provide hands-on support across key clinical supply chain activities, including forecasting, packaging and labeling coordination, inventory monitoring, distribution logistics, and IRT vendor management. The ideal candidate will bring strong operational expertise and the ability to work independently in a fast-paced environment while partnering cross-functionally with Clinical Operations, CMC, and external vendors. This is an opportunity to contribute meaningful support to an emerging clinical pipeline and help ensure continuity of critical clinical trial operations.

Responsibilities:

• Provide operational support for clinical supply management activities, including forecasting, packaging, labeling, distribution, inventory monitoring, and IRT vendor coordination.
• Partner with Clinical Operations to support clinical trial demand forecasting and supply planning activities.
• Collaborate with the CMC team to support development and execution of clinical supply plans, including shelf-life management considerations.
• Coordinate with external CDMOs supporting clinical packaging and labeling operations.
• Review and support approval of pre and post production documentation related to clinical supplies.
• Manage logistics coordination for domestic and global shipments of clinical trial materials.
• Support IRT activities, including system setup, testing, implementation, and ongoing management.
• Coordinate clinical label review and approval activities.
• Assist with development or refinement of clinical supply processes and supporting documentation/SOPs, as needed
• Identify and escalate potential supply risks and support continuous improvement initiatives within clinical supply operations

Qualifications:

• Bachelor's degree in business administration, supply chain management or related discipline, with 5+ years of clinical supply chain experience in pharmaceutical industry or equivalent experience
• Prior experience supporting clinical trial material planning and supply management
• Experience managing or coordinating external CMO/CROS and vendor relationships in a virtual environment
• Hands-on experience supporting IRT systems and vendors
• Solid understanding of cGMPs, clinical operations, and drug development processes
• Strong organizational and communication skills with the ability to effectively collaborate across functions
• Demonstrated analytical and problem solving skills with the ability to manage competing priorities in a dynamic environment
• Detail oriented with the ability to work independently and execute against aggressive timelines

Additional Information:

• This is a temporary contractor engagement anticipated to last approximately 3 months.
• This role will be hybrid in our Newark, CA office.

The anticipated annualized base pay range for this full-time position is $85.00 - $90.00 per hour. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. Ardelyx is an equal opportunity employer.