Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial; and FPI-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.
We are seeking a highly skilled and experienced Director of Clinical Supply Chain to lead and optimize our supply chain operations. The ideal candidate will have a deep understanding of the complexities involved in the production, storage, and distribution of these specialized therapies, ensuring seamless delivery to clinical sites and patients. Experience in cell therapy or radiopharmaceutical products is required.
Responsibilities:
1. Strategic Leadership
a. 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 uninterrupted IMP to patients.
b. Generate and maintain a clinical and/or commercial supply plan to drive manufacturing, labeling, and forecasting logistic supply activities across internal and external stakeholders.
c. 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.
d. 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.
e. Oversee the selection and management of third-party vendors from IMP management to systems.
f. Oversee the end-to-end supply chain process, from patient scheduling to IMP dosing/destruction in the conduct of a clinical trial ensuring compliance with all regulatory requirements and industry standards for the handling and transportation of IMP.
g. Act as a conduit between functions pertaining to supply, transportation, logistics, and traceability issues for IMP.
h. Work with colleagues and vendors to identify and procure ancillary, comparator and companion drugs to support studies.
i. Be a part of a team to build a high-performing clinical supply chain team, providing mentorship and development opportunities. Foster a culture of collaboration, innovation, and excellence within the team. Mentor and teach junior supply chain as well as non-clinical supply chain team members.
j. Ensure timely and accurate financial reporting and forecasting related to clinical supplies.
Qualifications:
• Bachelor’s degree in Supply Chain management, Business Administration, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 10 years of experience in supply chain management, with at least 5 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.
• Proven experience in cell therapy or radiopharmaceutical supply chain operations is a plus.
• 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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.