Job Title: Principal Scientist/ Team Lead
Responsibilities:
- Lead implementation of clinical biomarker strategy to enable target engagement characterization, PK/PD indication of biologic activity and assessment of patient response.
- Serve as a key contributor to integrate, influence, and execute on translational/biomarker plans.
- Communicate translational updates and conduct strategic discussions for key programs with diverse audiences, including senior management.
- Understand key cancer pathway interactions and feedback mechanisms in clinical samples to inform ongoing clinical trials.
- Define novel mechanisms of resistance by studying samples at relapse.
- Contribute relevant scientific expertise, strategy, and experimentally-derived insights as a member of multidisciplinary project teams working to drive the preclinical to clinical translation of pipeline assets.
- Plan, design, and execute IND-enabling pharmacology, pharmacokinetic and toxicology studies by applying knowledge of disease-associated pathways, preclinical models, and drug development.
- Contribute to the preparation of IND applications and other regulatory documents, as appropriate, leveraging up-to-date knowledge of FDA cellular therapy guidance.
- Establish and cultivate relationships with external CRO collaborators for basic and translational research.
- Maintain a current and comprehensive understanding of disease biology, treatment paradigm, and competitive landscape for key programs.
Experience:
- PhD, MD or MD/PhD degree in a relevant scientific field (e.g., cancer biology, immunology, hematology), with 8+ years post-degree experience, inclusive of 3+ years of experience in a formalized Translational Science/Medicine role within a large pharma/biotech company is required.
- Understanding of early or late-stage drug and translational development process, including clinical trial experience in industry or academia.
- In-depth understanding of myeloid disease biology (e.g., AML, MDS), knowledge of clinical landscape, evolving therapy, and competitive scenarios.
- Demonstrated record of research accomplishment as evidenced by publications or major contributions to drug development milestones.