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Senior Clinical Trial Manager

2 months ago

Boston, United States Fusion Pharmaceuticals Full time

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.


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
  • Collaborate with cross-functional AstraZeneca team members on specific programs
  • Work under AstraZeneca SOLIS Model on designated studies
  • 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)
  • 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.