Associate Director, Clinical Supply

Liquidia•,

About The Position

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

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.