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.
The Coordinator, Clinical Supply Chain will collaborate cross-functionally with internal Fusion stakeholders such as Clinical Operation, Regulatory, Pharmacovigilance, Quality, CMC teams and external vendors to ensure timing of clinical supply product deliverables are met across programs. Builds relationships with and acts as a key resource for IMP ordering status. Manages day to day clinical supply activities for Fusion clinical trial programs.
Responsibilities:
• Develop and maintain strong, collaborative relationships with key stakeholders with cross functional team including Quality, Clinical Operations, Radiation Science and CMC
• Manage the day-to-day activities related to clinical studies including scheduling of patient dosing, IMP requests, product documentation and site licensing
• Work with the Radio Pharm Manufacturing and Quality department to manage any issues that arise during shipping and/or receipt and communicate any delays to the clinical team. When applicable manage deviations and corrective/preventive actions
• Oversee patient dose scheduling, ordering, tracking, delivery and receipt of clinical supplies and drug to clinical sites within the US and ex-Us locations
• Support the development of clinical supply chain documents such as IMP request forms, patient dosing cards, pharmacy manuals and training materials
• Responsible for maintenance of internal SharePoint and Box files.
• Responsible for and/or aids CRO in set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files in accordance with eTMF plan.
• Ability to work independently when called for on assigned tasks.
Qualifications:
• Bachelor’s Degree (preferably in industry or healthcare of science field).
• Minimum of 2 years experience with clinical supply chain or equivalent experience
• Prior experience in radiopharmaceutical/pharmaceutical product distribution of Class 7 Dangerous goods including import/export is a plus
• Strong verbal and written communication and presentation skills
• Proficient in Microsoft programs such as Word, Excel, PowerPoint
• Proactively seeks out and recommends process improvements
• Flexibility in working hours to deal with global supply activities
• Have excellent written, verbal, and interpersonal communication skills and comfort working with multiple internal and external stakeholders.
• Must have 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 orientation, gender identity, national origin, disability, or status as a protected veteran.