Associate Director, Clinical Supply

This is a fully remote position, open to applicants in United States.

📋 Description

• Formulate and implement global clinical supply planning and forecasting for clinical trials spanning multiple countries and regions.

• Direct clinical supply planning for designated studies, encompassing forecasting, demand planning, labeling generation and authorization, supervision of packaging and labeling operations, material release and distribution, depot/site inventory management, IRT setup and maintenance, expiry and dating extension management, as well as cold-chain/temperature-excursion management.

• Ensure that supply strategies are in harmony with clinical schedules, protocol requirements, and specific regulatory constraints of each country.

• Spearhead demand and supply forecast modeling along with scenario planning for material and device planning at both the asset and study levels.

• Oversee comprehensive clinical supply activities, including coordination of IMP manufacturing, packaging, labeling, blinding, global distribution, and depot management.

• Assist with returns, reconciliation, and destruction processes.

• Supervise IRT/RTSM strategy and supply modeling.

• Keep track of depot and site inventory, manage resupply strategies, and alleviate supply risks to ensure a continuous patient supply.

• Manage and supervise CMOs, packaging vendors, depots, couriers, and IRT service providers.

• Establish and oversee vendor scopes of work, budgets, timelines, and performance metrics.

• Lead issue resolution and foster continuous improvement with external partners.

• Ensure adherence to global regulatory standards, including FDA, EMA, MHRA, PMDA, and GxP regulations.

• Assist with regulatory submissions and related documents, including clinical label text, clinical trial protocols, pharmacy manuals, IMPDs, INDs, and CTAs.

• Collaborate with Quality on audits, inspections, deviations, CAPAs, and change controls.

• Act as the clinical supply subject matter expert and primary liaison on cross-functional clinical program teams.

• Work together with Clinical Operations on study design considerations that influence supply forecasting and planning.

• Coordinate with CMC, Regulatory Affairs, Quality, and Manufacturing to align development and supply strategies.

• Provide ongoing updates to internal and external partners regarding supply planning, forecasting, timelines, risks, and mitigation strategies.

• Create and manage clinical supply budgets, monitor costs, and contribute to long-term supply planning and organizational strategy.

⛳️ Requirements

• A Bachelor’s degree or higher in Life Sciences, Engineering, Supply Chain, or a related field is required.

• Over 8 years of progressive experience in 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, as well as depot and site inventory management.

• Demonstrated experience in supporting global clinical trials throughout all phases of development across multiple countries and regions, including Phase I–III, IIR, and post-market studies.

• Practical experience with global labeling and packaging strategies.

• Practical experience with IRT/RTSM systems.

• Practical experience in vendor and CMO management.

• Familiarity with regulatory submissions related to clinical supply.

• Strong comprehension of global clinical supply chain operations and regulatory requirements.

• Solid understanding of GxP, ICH guidelines, and country-specific import/export regulations.

• Exceptional analytical and critical thinking abilities.

• Capability to formulate strategies and drive their implementation.

• Outstanding project management and problem-solving skills.

• Strong communication skills and ability to collaborate across functions.

• An entrepreneurial spirit coupled with a robust biotech start-up mindset and experience.

• Ability to handle multiple priorities in a dynamic environment.

• Experience with demand and supply planning simulation/forecasting tools.

• Domestic and international travel may be necessary, 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 accommodations for qualified individuals with disabilities