[Hiring] Senior Manager, Clinical Supply Chain @Entrada Therapeutics

Role Description

The Senior Manager, Clinical Supply Chain is an integral part of successfully executing Entrada’s clinical development strategy. This role ensures successful execution of clinical supply operations and partners cross-functionally to deliver uninterrupted clinical supplies for our global, multi-phase clinical trials.

• Lead Entrada’s clinical supply chain activities, including label text generation, labeling and packaging operations, global distribution, inventory management, and IP 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 IRT specifications for study product, product availability and release status, shipment authorizations, and maintenance of study blind integrity.
• Develop appropriate 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 the 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 IV infusion for clinical sites.
• Ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, GMP.

Qualifications

• Bachelor’s degree in supply chain, scientific or related field required with 8+ years of Clinical Supply Chain management in the pharmaceutical or biotechnology industry.
• Demonstrated experience planning and executing clinical supply strategies for complex, global clinical studies.
• Demonstrated experience managing clinical supply activities, including labeling, packaging, distribution, inventory management, product reconciliation, and forecasting.
• Experience supporting injectable programs requiring cold-chain storage and distribution.
• Demonstrated experience managing import and export activities for global clinical studies with a focus on North America and Europe.
• Strong operational and project management skills, with experience managing multiple programs, vendors, and deliverables simultaneously.
• Demonstrated proficiency working with 3rd party IRT systems, including IP-related specification development.
• Experience overseeing Unblinded Clinical Supply activities, including management of site pharmacy inquiries and temperature excursions.
• Excellent communication (verbal and written) and interpersonal skills.
• Ability to exercise independent judgment with minimal supervision.

Requirements

• This is a US based remote position, with preference given to local New England based candidates.
• This role will require minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

Benefits

• Comprehensive health, dental and vision coverage.
• Life and disability insurance.
• 401(k) match.
• Paid, gender-inclusive parental leave.
• Holistic support for health and well-being.
• Education reimbursement.
• Discretionary time off.
• Commuting benefits aligned to your working model.