Associate Director, Clinical Supply

Liquidia

23h

About The Position

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

Job Summary
We are seeking an experienced Associate Director, Clinical Supply, to join our growing Clinical Supply team.
You will be responsible for developing clinical supply chain planning and forecasting to ensure continuous uninterrupted availability of supply throughout the development lifecycle including comprehensive global depot and site inventory management. You also will be responsible for supporting organizational infrastructure, including developing and implementing clinical supply chain procedures and other cross-functional and independent projects to support the developing pipeline. This individual will collaborate with internal and external partners to ensure uninterrupted material availability including providing CMO and IRT vendor oversight.

Requirements

• Bachelor’s degree or advanced degree in Life Sciences, Engineering, Supply Chain, or related field required
• 8+ years of progressive experience with managing clinical supply activities including: bulk drug and device allocation planning, packaging and labeling forecasting and oversight, label creation/planning/design, global distribution and logistics, forecasting and demand planning and depot and site inventory management.
• Proven experience supporting global clinical trials across all stages of development in multiple countries and regions (Phase I-III, IIR and post market)
• Demonstrated hands-on experience with:
• Global labeling and packaging strategies
• IRT/RTSM system
• Vendor and CMO management
• Regulatory submissions related to clinical supply
• Demonstrated aptitude for ‘hands-on’ operations with an exemplary history as a “self-starter”
• Must be detail oriented with excellent communication and documentation skills

Nice To Haves

• Mechanical aptitude is a must, experience in the troubleshooting of production equipment preferred
• Ability to read, interpret and create technical equipment documentation such as user manuals, electrical/pneumatic schematics, and fabrication drawings.
• Experience with PLC and microcontroller programming and troubleshooting a plus
• Hands on experience with technical and/or experimental execution
• Ability to interpret data and summarize results
• Familiarity with statistical data analysis (DOE, process capability, hypothesis testing, ANOVA) a plus

Responsibilities

• Develop and execute global clinical supply planning and forecasting for clinical trials across multiple countries and regions (e.g., North America, EU, APAC).
• Lead clinical supply planning for assigned studies including forecasting, demand planning, labeling generation and approval, packaging and labeling operations oversight, material release and distribution, depot/site inventory management, IRT set-up and maintenance, expiry and dating extension management and cold chain/temperature excursion management.
• Ensure supply strategies align with clinical timelines, protocol requirements, and regulatory constraints in each participating country.
• Lead and perform demand and supply forecast modeling and scenario planning to enable comprehensive asset level and study level material and device planning.
• Manage end-to-end clinical supply activities, including: IMP manufacturing coordination
• Packaging, labeling, and blinding
• Global distribution and depot management
• Support returns, reconciliation, and destruction
• Oversee Interactive Response Technology (IRT/RTSM) strategy and supply modeling.
• Monitor depot and site inventory levels, manage resupply strategies, and mitigate supply risks to ensure continuous uninterrupted supply to patients.
• Manage, and oversee CMOs, packaging vendors, depots, couriers, and IRT providers.
• Establish and manage vendor scopes of work, budgets, timelines, and performance metrics.
• Lead issue resolution and continuous improvement with external partners.
• Ensure clinical supply activities comply with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA) and GxP standards.
• Support preparation and review of regulatory submissions and associated documents such as clinical label text, clinical trial protocol, pharmacy manual and IMPDs, INDs, CTAs.
• Partner with Quality to support audits, inspections, deviations, CAPAs, and change controls.
• Serve as the clinical supply subject matter expert and primary point of contact on cross-functional clinical program teams.
• Collaborate with Clinical Operations on study design considerations impacting supply forecasting and planning.
• Work closely with CMC, Regulatory Affairs, Quality, and Manufacturing to align development and supply plans.
• Provide comprehensive dynamic updates to internal and external partners on supply planning and forecasting, timelines, key risks and mitigations.
• Develop and manage clinical supply budgets.
• Track and control costs while ensuring adequate supply and compliance.
• Contribute to long-term clinical supply planning and organizational strategy.
• Mentor and coach clinical supply team members.
• Serve as a subject matter expert and develop continuous improvement plans, best practices, SOPs, and scalable processes to support pipeline growth.

Benefits

• Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level