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Entrada Therapeutics

Develops intracellular therapeutics using endosomal escape

Senior Manager - Clinical Supply Chain

Clinical Research OperationsPosted on Nov 13
Full-timeRemote in USA$156.5k - $183.4k

About the Job

Requirements

  • A bachelor's degree in supply chain, a scientific field, or a related field is required.
  • At least 8 years of clinical supply chain management experience in the pharmaceutical or biotechnology industry is required.
  • Demonstrated experience planning and executing clinical supply strategies for complex, global clinical studies is required.
  • Demonstrated experience managing clinical supply activities, including labeling, packaging, distribution, inventory management, product reconciliation, and forecasting is required.
  • Experience supporting injectable programs that require cold-chain storage and distribution is required.
  • Demonstrated experience managing import and export activities for global clinical studies, with a focus on North America and Europe, is required.
  • Strong operational and project management skills, including managing multiple programs, vendors, and deliverables simultaneously, are required.
  • Demonstrated proficiency working with third-party IRT systems, including IP-related specification development, is required.
  • Experience overseeing unblinded clinical supply activities, including management of site pharmacy inquiries and temperature excursions, is required.
  • Excellent verbal and written communication and interpersonal skills are required.
  • Ability to exercise independent judgment with minimal supervision is required.

Responsibilities

  • Lead clinical supply chain activities, including label text generation, labeling and packaging operations, global distribution, inventory management, and investigational product reconciliation.
  • Develop and maintain comprehensive supply plans aligned with clinical enrollment projections, dosing requirements, regulatory timelines, and clinical study milestones.
  • Provide operational oversight of contract organizations involved in packaging, labeling, and distribution.
  • Author, review, and approve clinical label text, multi-country clinical label designs, packaging batch records, pharmacy manuals, and clinical supply sections of study-related documents.
  • Manage investigational product aspects of IRT systems, including study product IRT specifications, product availability and release status, shipment authorizations, and maintenance of study blind integrity.
  • Develop supply risk-mitigation strategies and proactively identify and manage risks related to study timelines, supply availability, expiry, inventory levels, and protocol updates.
  • Partner with Quality and Clinical stakeholders to facilitate timely review, approval, and execution of standard operating procedures, batch records, lot-release documentation, change controls, deviations, investigations, and corrective and preventive actions.
  • Manage sourcing of ancillary supplies for intravenous infusion at clinical sites.
  • Ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, and GMP.

About the Company

Entrada Therapeutics

Develops intracellular therapeutics using endosomal escape

Entrada Therapeutics focuses on developing a new class of medicines to treat devastating diseases by delivering therapies inside cells. Its core technology, the Endosomal Escape Vehicle (EEV) platform, helps drugs escape from endosomes—cellular compartments that often trap or degrade treatments—so they can reach intracellular targets. The product pipeline centers on EEV-therapeutics, including candidates for Duchenne muscular dystrophy and other neuromuscular diseases, with ENTR-601-45 currently cleared by UK and EU regulators to begin clinical trials. What sets Entrada apart is its explicit emphasis on enabling intracellular delivery to access targets that were previously hard to treat, using a platform-agnostic delivery approach that can work with a range of therapeutics such as oligonucleotides. The company’s goal is to advance multiple EEV-therapeutics through clinical development to address rare and other hard-to-treat diseases and reach patients who need new treatment options.

Company size
201-500
Company stage
IPO
Headquarters
Boston, MA
Founded
2016

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