- Develop and maintain strong, collaborative relationships with key stakeholders with cross functional team including Quality, Clinical Operations, Radiation Science and CMC
- Ensures that key project milestones are met; negotiates and communicates clinical supply plan timelines to internal and external stakeholders and partners
- Manage the day-to-day activities related to clinical studies including scheduling of patient manufacturing, 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 and manufacturing scheduling, ordering, tracking, delivery and receipt clinical supplies and drug to clinical sites within the US and ex-Us locations
- Develop supply chain documents such as drug request forms, patient dosing cards, pharmacy manuals and training materials
- Facilitate the implementation of the IRT system for drug management
- Active participation in the life cycle of a protocols design and execution to ensure an executable supply chain strategy
- Contribute the development of system, tools and processes for projecting clinical supply demand and tracking
- Serve as an escalation point for Clinical Operations, sites, and CROs
- Participate in functional initiatives, including SOP development and review, staff training, and system/process improvement
- Participate in site training as needed.
- Bachelor's Degree
- Minimum of years experience with clinical supply chain, Phase I-III
- Prior experience in radiopharmaceutical/pharmaceutical product distribution of Class 7 Dangerous goods including import/export is a plus
- Knowledge of ICH GCP Guidelines and local and international regulatory requirements
- Demand planning, forecasting and analytical skills
- Advanced problem-solving ability
- Flexibility in working hours to deal with US/EU and Australian 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.
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Senior Manager/Associate Director, Clinical Supply Chain - Providence, United States - Fusion Pharmaceuticals LLC
Description
Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals 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-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion's growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.
The Senior Manager/Associate Director, 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 needs are met across programs. Builds relationships with and acts as a key resource and escalation point. Lead the creation of the clinical supply strategy for a study and program; translates strategic objectives into plans for team execution. Works within clinical drug supply as well as cross-functionally to develop consistent practices. Manages day to day clinical supply activities for early-stage programs.
Do you have the skills to fill this role Read the complete details below, and make your application today.
Responsibilities:
Qualifications:
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.
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