Associate Director, Clinical Supply Chain

Merida Biosciences•Cambridge, MA

About The Position

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases. The Associate Director, Clinical Supply Chain will lead hands-on clinical supply planning and execution across global Phase 1 and Phase 2 studies. This role owns clinical supply operations through an outsourced network of packaging, depot, distribution, and logistics partners and works closely with Clinical Operations, CMC, Quality, and Regulatory to ensure uninterrupted and compliant study supply. The ideal candidate is a practical operator who can manage complexity, build fit-for-purpose processes, and execute effectively in a lean biotech environment.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.
8+ years supply chain experience in biotech or pharmaceutical organizations, including direct responsibility for global clinical trial supply execution.
Strong experience in demand forecasting, supply planning, and outsourced vendor management.
Experience supporting global or multi-region clinical studies.
Experience with packaging, labeling, depot oversight, and temperature-controlled distribution for clinical materials.
Demonstrated ability to operate independently and effectively in a lean biotech environment.

Nice To Haves

Experience supporting clinical supply in complex import/export environments (e.g., China, Australia) and managing multi-country labels.
Experience with comparator and ancillary supply strategy and execution.
Experience supporting blinded studies and IRT-enabled supply planning.
Experience with frozen biologic or frozen drug product supply chains.
Experience in emerging biotech or start-up environments.

Responsibilities

Lead end-to-end clinical supply planning and execution for global clinical studies across investigational product and supporting clinical materials.
Develop and maintain demand forecasts and supply plans based on enrollment, dosing, regional activation, manufacturing lead times, and protocol changes.
Partner with Clinical Operations on IRT strategy and setup, including supply parameters, forecasting assumptions, and ongoing change control.
Define and manage depot strategy, distribution plans, and global shipping/logistics, including management of temperature-controlled distribution and external depot/logistics partners.
Manage external partners responsible for packaging, labeling, storage, and distribution of IMP and comparator/ancillary materials, including performance, timelines, budgets, and issue escalation.
Partner with Clinical Operations, CMC, Quality, and Regulatory to align supply plans with manufacturing, release, labeling, and study execution needs.
Author study pharmacy manuals in collaboration with Clinical Operations, CMC, and other functions as needed.
Support packaging and release readiness in partnership with Quality, including deviation/investigation support, temperature excursion assessment, and disposition planning as needed.
Identify supply risks early and drive practical mitigation plans to protect study continuity, compliance, and timelines.
Establish fit-for-purpose processes, reporting and governance for clinical supply activities appropriate for an emerging biotech organization.