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Senior Clinical Trial Manager/Clinical Trial Manager
Location:
Boston, MA
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; 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. Responsibilities: Work closely with Clinical Operations and Development Team in generating and overseeing study plan(s) Leads and manages internal and external clinical operation activities for complex clinical study(ies). Oversees daily activities and deliverable of CRO Contributes significantly to relevant study documentation including project plans; implements and monitors progress against project plans and revises as necessary Reviews and authors applicable sections of clinical protocols, CRFs, study reports, IB and informed consent forms Proactively identifies project risks and develops resolution plans Participates in the selection of Investigators and vendors Participates in study data review and assists with site management to ensure data quality/timely data entry Responsible for managing approved study budget(s) against trial progress and bring deviations to department leads. Review and approve Vendor invoices, including investigator grants and pass through costs. Assists with the negotiation & establishment of contracts and budgets with external clinical sites and vendors Collaborate with CMC and clinical supply colleagues to properly project for drug supply needs Track record of strong study management showing clear proficiency in clinical project management skills Solid vendor management skills Broad understanding of operations including those in related development functions Demonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug development Demonstrates ability to effectively interface with key medical personnel at clinical site(s) Demonstrates ability to lead multi-disciplinary teams Demonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of data Maintains a flexible, can-do approach to address issues proactively and innovatively Possesses excellent written and oral communication skills Qualifications B.S. degree or equivalent, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) Minimum of 3-5 years for a CTM and 5-8 years for a Senior CTM of clinical trial management experience in the pharmaceutical, biotech and/or CRO industry Oncology therapeutic area experience is required for this position. Phase 1 and/or 2 experience preferable Working knowledge of ICH Good Clinical Practice guidelines Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors Experience and ability to manage global or regional teams in a virtual environment Proven track record in successfully managing trials from start-up to database lock Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues Must be adaptable and enjoy working in a fast-paced environment Effective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverables Willingness to travel up to 10-20% of time 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. PDN-9bdf85a1-0172-44ba-9bdf-2a79adb4ccdf
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More About this Listing: Senior Clinical Trial Manager/Clinical Trial Manager
Senior Clinical Trial Manager/Clinical Trial Manager is a Executive Manager Job at Fusion Pharmaceuticals located in Boston MA. Find other listings like Senior Clinical Trial Manager/Clinical Trial Manager by searching Oodle for Executive Manager Jobs.
Senior Clinical Trial Manager/Clinical Trial Manager is a Executive Manager Job at Fusion Pharmaceuticals located in Boston MA. Find other listings like Senior Clinical Trial Manager/Clinical Trial Manager by searching Oodle for Executive Manager Jobs.