Fusion Pharmaceuticals
  • Boston, MA, USA
  • Full Time

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Employing its platform technology, including proprietary Fast-Clear linker, Fusion connects alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the payloads to tumors. Fusion's lead program, FPI-1434, is currently in a Phase 1 clinical trial. The Company is growing a pipeline of precision oncology therapies in development, and recently announced a collaboration agreement with AstraZeneca. Following Fusion's June 2020 IPO, the Company has cash to fund operations into 2023.

The principal scientist/associate director of ADME/Toxicology is accountable for planning, oversight, and delivery of nonclinical toxicology, ADME, and pharmacokinetics data packages in support of preclinical and clinical stage targeted alpha therapeutics. This role will report to the Director of Preclinical Development.

Duties & Responsibilities:

  • Apply a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate ADME/toxicology studies and development plans
  • Provide creative approaches to expedite clinical nonclinical development strategies
  • Oversee external vendors and consultants supporting ADME/Tox studies
  • Provide a critical review of toxicology study protocols, data, and study reports
  • Serve as the toxicology representative on cross-functional project teams supporting discovery and development phase projects
  • Contribute to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
  • Effectively communicate ADME/PK/toxicology study results to project teams and senior level management
  • Lead the development and execution of bioanalytical techniques supporting pharmacokinetic and PK/PD studies for targeted alpha therapeutics

Qualifications:

  • PhD in a scientific field of study such as biology, pharmacology, toxicology, or a related field with a minimum of 3 years of industry experience as part of a drug development project team. Candidates with a BS/MS and appropriate industry experience will be considered.
  • Relevant nonclinical development experience at a pharmaceutical or biotechnology company
  • Understanding of industry standards and applicable regulatory guidelines, including FDA regulations and ICH guidelines
  • Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
  • Experience overseeing and interacting with CROs, consultants, or other third parties in the conduct of nonclinical safety and/or ADME/PK studies
  • Experience in authoring nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
  • Strong collaboration and cross-functional communication skills

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
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