- Scientific and technical leader in quantitative biomarker assay development at TCAL. Responsible for providing input into research strategies, and collaborating with global Takeda sites for the advancement of the portfolio, translational medicine and pre-clinical biomarker efforts for programs to IND filing.
- Support drug discovery and early development programs by providing relevant scientific and strategic input with respect to quantitative analytics of biomarkers, PK-PD, and translational research strategy.
- Design, execute, and report key biomarker data to support compound progression and translational research strategy for programs from target loading through early clinical development
- Work with project teams to address biomarker strategy through candidate selection
- Collaborate with biology, pharmacology, and modeling and simulation colleagues to design and conduct PK/PD and/or efficacy studies to support translation and clinical dose setting
- Evaluate and develop biomarker assays via LC-MS/MS technologies, ligand-binding assays, or other appropriate assay systems
- Contribute equally with other project team members on high level project strategy
- Work closely with department colleagues to coordinate work for project teams
- Is responsible for ensuring strong alignment and interfaces with DMPK groups across US affiliates and Japan Discovery and Development
- Keep an accurate notebook according to company policy
- Communicate with colleagues effectively
- Follow company safety procedures
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
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- PhD with post doc in Pharmacology/Biochemistry/Life Science or related coursework with 4+ years of relevant industry experience OR MS/MA with 14+ years OR BS/BA 16+ years industry experience.
- Experience in developing fit-for purpose biomarker assays for the measurement of proteins, peptides, and antibodies
- Expertise in development of quantitative analytical bioassays from complex matrices is required
- Thorough understanding of application of biomarkers to understanding exposure-effect relationships.
- Ability to identify and implement (where and when appropriate) new technologies for the advancement of quantitative biomarker analytics
- Must be able to manage assay development and analysis queues and timelines
- Knowledge of drug discovery process, DMPK function and pharmacology is required
- Demonstrated ability to solve scientific problems creatively, effectively and independently
- Demonstrated ability to work within a matrix and team environment
- Excellent oral and written communication skills
- None required
- Manual dexterity required to operate standard laboratory and office equipment
- Carrying, handling and reaching for objects
- Exposure to hazardous/toxic/dangerous chemicals
- Prolonged standing and/or sitting.
- May travel to various domestic conferences or client sites, including overnight trips
- Some international travel may be required
- Requires a minimum of 2% travel
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