Early Oncology Clinical Safety Postdoctoral Fellow
4 weeks ago
Oncology Early Development Safety Team
The oncology early development (OED) safety team is comprised of physicians (MD) who are experts in the early drug development/early oncology space. The postdoctoral fellow will work closely with the OED safety team as well as other cross functional members of the oncology early development team (e.g. preclinical safety and toxicology, discovery, pharmacology and pharmacokinetics, regulatory, statistics) bridging preclinical/discovery expertise to the very early phases of clinical safety (e.g. pre-IND interactions, and IND submission and initial FIH phase). This is a 12-month assignment.
Job responsibilities:
- MOA experts and connectors across assets within OED safety and with oncology late-stage safety.
- Liaison between the clinical safety team and discovery leads on newly explored target/platforms in oncology.
- Analyze and summarize a wide range of data (safety preclinical/animal data and early safety clinical data) and literature (safety pre-clinical and safety early clinical) and interpret them, in collaboration with the safety physician, to understand how they can impact the safety aspects of IND submission preparation and the FIH trial strategy (inclusion exclusion criteria, safety monitoring, potential safety concerns to be closely monitored)
- Influence stakeholders and programs using an in-depth understanding of molecules chemical constructs, cellular and gene pathways and ability to translate it into the theoretical on-target safety liabilities for FIH trials.
- Safety point of contact for early programs/platforms, partnering with PSTL and cross-functional teams especially in the very early phases: from before Candidate Nomination to IND submission.
- This position requires a Ph.D, with a strong scientific background in Oncology research (basic and/or clinical). Spring graduates are encouraged to apply
- Strong understanding of scientific concepts and have experience in translational research and biomarker development.
- Knowledge of preclinical and clinical development is a prerequisite, as is knowledge of Immuno-Oncology and emerging therapies in Oncology.
- Excellent written English communication and oral presentation skills.
- Willing to work onsite three days a week.
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