- Develops and executes translational science and biomarker development plans and defines patient selection strategies for clinical studies
- Provides key specifics on the mechanism of action, biomarker identification and patient selection strategies
- Contributes to overall development strategy and trial design, incorporating biomarker endpoints
- Works with clinical team for implementation of biomarker sample collection and bioanalysis
- Drives clinical biomarker data analysis and interpretation
Contributes to clinical documents:
protocols, IBs, study reports, statistical analysis plans, publications, CSR and biomarker sections of regulatory submissions
- Leads reverse translation, so that clinical results can be used to inform development strategy
- Contributes to greater understanding of the mechanism of action to enable clinical translation
- Thinks strategically and drives innovation. Identifies and leads the evaluation of state -of- the- art technologies for translational and biomarker research
- Establishes and leads Translational Medicine focused external collaborations (変更の範囲) 会社内での全ての業務 【応募要件 / Qualifications】
- Advanced science degree (PhD, PharmD, or MD) with primary focus in human genetics, molecular biology, or virology
- A minimum of 7 years relevant experience in drug discovery and development in biotech/pharmaceutical company or equivalent translational research experience at an academic institution.
- Broad knowledge and first-hand experience in translational development of gene therapy or cell therapy
- Extensive experience in clinical biomarker assay development, qualification and clinical implementation
- Proven record of leading teams and obtaining high quality and timely results through influencing in a matrix environment
- Demonstrated success in delivering high quality clinical biomarker data to inform decisions and development strategy
- Broad technical experience in DNA, RNA, and protein-based biomarker assays (e.g. PCR, NGS, ELISA/MSD, IHC)
- An innovation mindset with track record of incorporating new technologies in translational and biomarker research
- Strong communication skills (oral, written, and presentations), interpersonal, influencing, and overall leadership skills
- Translational development experience in rare diseases
- Experience in managing CRO work
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