Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers. Using its proprietary Fast-Clear Linker technology platform, Fusion attaches medical isotopes to targeting molecules creating novel, next-generation cancer treatments. In preclinical studies, the Company has shown the ability to precisely target and effectively kill solid tumor cells while minimizing the impact to healthy tissue. Fusion's lead program, FPI-1434, is currently in a Phase 1 trial. The Company completed an oversubscribed $125M Series B financing that will be used to advance FPI-1434 and initiate preclinical and clinical development on multiple new agents. Fusion is supported by a strong syndicate of investors and has ambitious goals to expand its pipeline.
We are seeking a highly motivated, experienced Scientist/Sr. Scientist, PK/PD to fill the newly created role reporting to the Director of Pre-Clinical Development. This individual will serve as a PK/PD/pharmacometric expert on project teams from early discovery through clinical development and lead activities pertaining to PK/PD study design and interpretation, translational PK/PD, and clinical PK/PD. In addition, the selected candidate will provide mechanistic and quantitative PK/PD expertise to support drug development and discovery teams to optimize targeted alpha therapeutic dosing strategies. In this role, significant opportunities exist to contribute to the PK/PD/pharmacometric strategy and mechanistic understanding of optimal dosing strategies for targeted alpha therapies. Applicants should be self-starters with well-developed communication skills who have demonstrated the ability to work effectively in a team driven, rapidly evolving, interactive scientific environment.
- Lead the implementation of model-based drug development strategies for preclinical and clinical targeted alpha therapeutic programs
- Execute relevant pharmacometric analyses: non-compartmental PK, PK/PD analyses, population PK and PK/PD, and other fit-for-purpose modeling and simulation activities as appropriate. Experience with PBPK modeling and/or disease and systems biology modeling a plus.
- Apply analytical methods in PK/PD/Pharmacometrics to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease progression in support of optimal study designs and interpretation of study outcomes.
- Contribute to translational science efforts and interact with discovery teams to provide PK/PD expertise to guide the selection of targeted alpha therapeutic candidates possessing desirable clinical PK/PD properties
- Provide PK/PD/Pharmacometrics contributions to regulatory documents as required for regulatory meetings and filings. Provides resolution of PK/PD/Pharmacometrics queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries
- PhD degree in Pharmacokinetics-Pharmacodynamics, Pharmacometrics, biomedical engineering, statistics, applied mathematics, computer science, or a related field
- 3 year of life science experience, preferably at a pharmaceutical or biotechnology organization, and broad familiarity with the drug development process
- Hands-on experience in utilizing WinNonLin, NONMEM and/or other modeling and simulation software is required. Experience with PBPK modeling, population PK, and mechanistic PK/PD modeling or systems pharmacology (QSP) is a plus
- Excellent interpersonal, collaboration, English communication skills (both written and verbal)
- Strong analytical skills and strategic thinking
- Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.