Senior Clinical Trial Manager/Clinical Trial Manager - Everett, 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.


Fusions 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 Fusions TATs and AstraZenecas 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 Mercks KEYTRUDA (pembrolizumab) in patients with solid tumors expressing IGF-1R.

To support Fusions 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 CROContributes significantly to relevant study documentation including project plans; implements and monitors progress against project plans and revises as necessaryReviews and authors applicable sections of clinical protocols, CRFs, study reports, IB and informed consent forms Proactively identifies project risks and develops resolution plansParticipates in the selection of Investigators and vendorsParticipates in study data review and assists with site management to ensure data quality/timely data entryResponsible 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 vendorsCollaborate with CMC and clinical supply colleagues to properly project for drug supply needsTrack record of strong study management showing clear proficiency in clinical project management skillsSolid vendor management skillsBroad understanding of operations including those in related development functionsDemonstrates detailed understanding of clinical protocol, intended study populations as well as solid overall drug developmentDemonstrates ability to effectively interface with key medical personnel at clinical site(s)Demonstrates ability to lead multi-disciplinary teamsDemonstrates ability to flag processes that may not be appropriate for study based on phase, design, and/or use of dataMaintains a flexible, can-do approach to address issues proactively and innovativelyPossesses excellent written and oral communication skillsQualificationsB.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 industryOncology therapeutic area experience is required for this position.

Phase 1 and/or 2 experience preferableWorking knowledge of ICH Good Clinical Practice guidelinesRequires 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 environmentProven 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 issuesMust be adaptable and enjoy working in a fast-paced environmentEffective leadership skills and proven ability to foster team productivity, cohesiveness, and quality deliverablesWillingness to travel up to 10-20% of timeAll 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.

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