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Fusion Pharmaceuticals · 1 month ago

Associate Director, Clinical Supply Chain

Boston, Boston, MA, US

Full-time

Hybrid

Senior Level, Lead/Staff, Director/Executive

$116K/yr - $174K/yr

7+ years exp

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates as precision medicines. The Associate Director of Clinical Supply Chain will lead and optimize supply chain operations, ensuring the seamless delivery of specialized therapies to clinical sites and patients.

BiopharmaBiotechnologyMedicalOncologyPharmaceutical

Responsibilities

Develop and implement a comprehensive global supply chain strategy including robust contingency plans for investigational medicinal products to support Fusion medicinal assets and studies including radiopharmaceutical products. Ensure transparency with key stakeholders to ensure efficiency and delivery of uninterrupted IMP to patients

Generate and maintain a clinical and/or commercial supply plan to drive manufacturing, labeling, and forecasting logistic supply activities across internal and external stakeholders

Create strong relationships with key stakeholders through collaboration with cross-functional teams, including client and internal Clinical Operations, CMC, manufacturing, quality assurance, and regulatory affairs, to align supply chain activities

Design and implement processes and policies to enable inspection readiness for the management of clinical supply chain activities

Implement systems or processes based on a fit for purpose model to ensure integrity and quality of IMP

Lead implementation, standardization, and continuous improvement of clinical supply chain systems and processes, including validation, user acceptance testing, and documentation to ensure compliance and scalability

Oversee the selection and management of third-party vendors from IMP management to systems

Act as a conduit between functions pertaining to supply, transportation, logistics, and traceability issues for IMP

Work with colleagues and vendors to identify and procure ancillary, comparator and companion drugs to support studies

Build and mentor a high-performing clinical supply chain team, fostering a culture of collaboration, innovation, and operational excellence

Understands the processes, technology and services the study team relies on, their needs and pain points. Using this knowledge to supply advice and guidance, removes barriers, supplies solutions and finds opportunities for improvement

Ensure timely and accurate financial reporting and forecasting related to clinical supplies

Serve as Business Owner for IRT, Labeling and forecasting, planning & inventory platforms, ERP; governing process design, data standards, integration, validation, and change control

Champion digital fluency and continuous improvement; mentor teams on systems, documentation, and governance

Qualification

Supply chain managementLeadership in pharmaceuticalIRT/XRS systemsRegulatory knowledgeForecasting/Planning eSystemsCommunication skillsNegotiation skillsCollaboration skills

Required

Bachelor's degree in supply chain management, Business Administration, Life Sciences, or a related field

High level of business process, technology and Clinical Study information knowledge

Minimum of 7 years of experience in supply chain management, with at least 5 plus years in a leadership role within the pharmaceutical industry

IRT/XRS, Forecasting/Planning eSystems experience to design, implement and maintain systems used to automate clinical supply chain operations

Strong knowledge of regulatory requirements and industry standards for clinical supply chains

Excellent leadership, communication, negotiation skills, and the ability to work collaboratively with cross-functional teams

Flexible in working hours to deal with global time zones as needed

Must be willing to step in and perform all aspects of the clinical supply chain core functions when needed to ensure successfully support of patient dosing

Have a sense of urgency and be comfortable pulling together stakeholders to make quick decisions as needed

10-15% travel to as needed