Translational Medicine Principal Scientist
- Serves as translational medicine expert on cross-functional project teams and develops translational medicine and biomarker strategy for one or more projects from lead optimization through IND; works with discovery team to vet potential ideas for target engagement and proof of mechanism markers
- Develops and validates clinical assays at outsourced partner laboratories using multiple assay technology platforms (e.g., cell-based assays, molecular-based assays, single or multiplexed immunoassays, flow cytometry and/or imaging technologies)
- Works with clinical development team to oversee seamless implementation of translational assays in the clinic, and to review and interpret assay data and results coming back from the clinic
- Helps review and author translational medicine-related clinical documentation, including: clinical protocols, study reports, consent forms; abstracts and/or manuscripts and regulatory documents (e.g. IND, IB etc.)
- Drives internal translational medicine initiatives to support clinical understanding and advancement of clinical stage programs working through CROs
- Presents translational medicine data packages internally and externally
- Effectively coordinates and manages external collaborations with academic partners and CROs to deliver results on time and on budget
- Monitors developing biomarker approaches and incorporate novel technologies in support of ongoing and new clinical programs
- PhD with postdoc or MS with minimum 3 years of experience in cellular/molecular biology, immunology or oncology required. 5+ years of industry experience in drug discovery and/or translational medicine required.
- Hands-on experience with and expert understanding of molecular and cellular techniques, such as PCR, IHC/IF, flow cytometry, NGS assays and their application in clinical trials.
- Ability to independently design, execute, and interpret experiments and communicate experimental results.
- Track record of working effectively with CROs to design and execute studies.
- Experience in validating clinical sites or central labs for implementation of clinical assays preferred.
- Experience of regulatory environment supporting development of LDT and CDx assays for oncology indications a plus.
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