Associate Director, Clinical Supply

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
Education and Experience

• 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 systems
  • Vendor  and CMO management
• Regulatory submissions related to clinical supply

Knowledge, Skills, and Abilities

• Strong understanding of global clinical supply chain operations and regulatory requirements
• Solid knowledge of GxP, ICH guidelines, and country-specific import/export requirements
• Strong analytical and critical thinking skills
• Ability to see the strategy and strong capability to drive implementation
• Excellent project management and problem-solving skills
• Strong communication and cross-functional collaboration abilities
• Entrepreneurial spirit; strong biotech start-up mindset and experience  
• Ability to manage multiple priorities in a fast-paced environment
• Experience with demand and supply planning simulation/forecasting tools
• Domestic and international travel may be required (approximately 10–20%)

Responsibilities
Global Clinical Supply Strategy & Execution

• 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.

Operational Oversight

• 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.

Vendor & Partner Management

• 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.

Regulatory & Quality Compliance

• 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.

Cross-Functional Leadership

• 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.

Budget & Resource Management

• 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.

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!
 
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
 
Recruiting Agencies, Please Note:
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.