Associate Director / Director, Clinical Supply Chain

Company Overview

AirNexis Therapeutics is a clinical-stage biotechnology company based in Palo Alto, California. Backed by an experienced leadership group and a strong investor base, the company is focused on bringing forward a next-generation maintenance treatment for COPD that may offer better efficacy and a more patient-friendly experience than current options. Using its licensed asset and late-stage development focus, AirNexis is working toward building a meaningful position in respiratory therapeutics. Its lead program, AN01, is a dual PDE3/PDE4 inhibitor designed to combine bronchodilatory and anti-inflammatory effects in a single therapy.

Role Summary

The Associate Director/Director, Clinical Supply Chain will own the strategic planning, day-to-day execution, and overall governance of clinical supply activities supporting global development programs. The role is responsible for keeping investigational medicinal products, comparators, ancillary materials, and related supplies continuously available across every stage of clinical development while meeting GMP expectations, regulatory requirements, and business objectives.

This position works in close partnership with Clinical Operations, CMC/Technical Operations, Regulatory Affairs, Quality Assurance, Manufacturing, and third-party vendors to design and carry out supply plans that align with study timelines and organizational goals.

Clinical Supply Strategy

• Create and roll out global clinical supply strategies, with particular emphasis on Phase II and Phase III studies.
• Lead forecasting, inventory control, supply planning, and distribution execution.
• Identify supply-chain risks and put mitigation plans in place to protect trial continuity.
• Support development plans with long-range forecasting and scenario-based planning.

Supply Planning and Execution

• Oversee production scheduling as well as clinical packaging, labeling, storage, and distribution processes.
• Manage investigational product flow from manufacturing through delivery to patients.
• Track inventory across depots, clinical sites, and distribution channels.
• Coordinate returns, reconciliation, destruction, and product accountability activities.

Vendor and External Partner Management

• Evaluate, select, and manage CROs, depots, logistics partners, packaging vendors, and IRT/RTSM providers.
• Define service expectations and measurable performance standards.
• Run business reviews and drive ongoing improvements with suppliers.

Compliance and Quality

• Maintain compliance with GxP, GMP, GDP, ICH, FDA, EMA, and other applicable global requirements.
• Assist with audits, inspections, deviations, CAPAs, and quality-related investigations.
• Keep supply documentation, SOPs, and controlled records accurate and current.

Financial Management

• Build and manage clinical supply budgets.
• Track actual spend against projections and look for opportunities to reduce cost.
• Support vendor negotiations and broader supplier-management work.

Qualifications

• A bachelor’s degree in Supply Chain, Engineering, Life Sciences, Pharmacy, Business, or a closely related field is required.
• An advanced degree such as an MBA, MS, or PharmD is preferred.
• At least 10 years of experience in pharmaceutical, biotech, or clinical supply chain roles.
• Background supporting Phase I through Phase III clinical trials.
• Experience leading global clinical supply programs and teams.

Additional Information

The seniority level for this position will be determined based on the candidate’s background, skills, and qualifications.