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Associate Director, Oncology, Translational Medicine
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- Work closely with other matrix functional areas to define key aspects of the integrated development plans, including the assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications.
- Collaborate with Biomarkers Lead(s) to define strategy for clinical stage programs, including design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions, and responses (INDs/CTAs) as well as co-authoring, assisting, and supporting the development of publications, abstracts, and presentations.
- Partner with biostatisticians and biomarker experts to ensure high-quality data to support analysis, interpretation, and reports for internal decision-making.
- Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development)
- Understanding of the entire Oncology development process, including clinical and non-clinical study design, use of immunologic surrogates, assay development and importance of target product profile.
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