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.

Fusion Pharmaceuticals jobs

Senior Clinical Trial Manager