Associate Director, Clinical Supply

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 10%

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• Develop and execute global clinical supply planning and forecasting for clinical trials across multiple countries and regions. • 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 setup and maintenance, expiry and dating extension management, and cold-chain/temperature-excursion management. • Ensure supply strategies align with clinical timelines, protocol requirements, and country-specific regulatory constraints. • Lead demand and supply forecast modeling and scenario planning for asset-level and study-level material and device planning. • Manage end-to-end clinical supply activities, including IMP manufacturing coordination, packaging, labeling, blinding, global distribution, and depot management. • Support returns, reconciliation, and destruction. • Oversee IRT/RTSM strategy and supply modeling. • Monitor depot and site inventory, manage resupply strategies, and mitigate supply risks to ensure uninterrupted patient supply. • 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 compliance with global regulatory requirements, including FDA, EMA, MHRA, PMDA, and GxP standards. • Support regulatory submissions and associated documents, including clinical label text, clinical trial protocols, pharmacy manuals, IMPDs, INDs, and CTAs. • Partner with Quality on audits, inspections, deviations, CAPAs, and change controls. • Serve as the clinical supply subject matter expert and primary contact on cross-functional clinical program teams. • Collaborate with Clinical Operations on study design considerations affecting supply forecasting and planning. • Work with CMC, Regulatory Affairs, Quality, and Manufacturing to align development and supply plans. • Provide dynamic updates to internal and external partners on supply planning, forecasting, timelines, risks, and mitigations. • Develop and manage clinical supply budgets, track costs, and contribute to long-term supply planning and organizational strategy.

🎯 Requirements

• Bachelor’s degree or advanced degree in Life Sciences, Engineering, Supply Chain, or related field required. • 8+ years of progressive experience 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, including Phase I–III, IIR, and post-market studies. • Hands-on experience with global labeling and packaging strategies. • Hands-on experience with IRT/RTSM systems. • Hands-on experience with vendor and CMO management. • Experience with 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 develop strategy and drive implementation. • Excellent project management and problem-solving skills. • Strong communication and cross-functional collaboration abilities. • Entrepreneurial spirit and 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%.

🏖️ Benefits

• Competitive compensation package • Medical insurance • Dental insurance • Vision insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) Savings Retirement Plan • Employee Stock Purchase Plan (ESPP) • Reasonable accommodation for qualified individuals with disabilities