- Serves as a functional leader and is responsible for overseeing and managing research activities within the DMPK department and for the development and mentoring of the DMPK team members. Develops and integrates the DMPK strategy to maximize value of Takeda California (TCAL) drug discovery programs. Ensures selection and utilization of appropriate in vitro, in vivo, or in silico methods and models to address absorption, metabolism and pharmacokinetic-related DMPK issues. Additionally, establishes PK/PD/E models in support of lead programs across several therapeutic areas, including: GI, Immunology and CNS.
Qualifications EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Provides strategic and hands-on leadership relating to DMPK (including PK and in vitro ADME), to address absorption, metabolism and pharmacokinetic issues for small molecules and biologics
- Independently conducts PK and PK/PD analysis during late stage lead optimization through early pre-clinical development, and collaborates in PK/PD and efficacy study design to support clinical dose setting
- Ensures strong alignment and interfaces with DMPK groups across US affiliates and Japan Discovery and Development.
- Provides leadership to enable project teams to make maximally informative decisions regarding selection and stage up of discovery compounds for pre-clinical development in , Immunology and CNS areas.
- Collaborates with safety assessment group on study design, provides toxicokinetic data analysis and interpretation, and ensures strong alignment with Takeda development partners (Millennium, Japan, TPUS).
- Formulates and executes research goals; recommends, designs, and/or executes experiments, utilizing a wide variety of scientific principles and novel methods to solve challenging scientific problems across multiple projects.
- May serve as co-leader on TCAL cross-functional drug discovery programs or on global working groups as required.
- Manages other PhDs and/or Research Associates; typically a combination of direct and indirect reports; provides mentoring career development to scientific staff.
- Protects TCALs intellectual property and grows its external presence through an ongoing commitment to the production of high quality patents, presentations, and publications.
- PhD in Pharmaceutical Sciences/Chemistry/Biochemistry or related coursework and 4-8+ years of relevant experience, or MS/MA with 14-18+ or BS/BA with 16-20+ years experience. Supervisory experience is highly preferred.
- Deep expertise in DMPK of both small molecules and biologics, knowledge in PK/PD/E modeling and application to clinical dose setting and predicting human efficacious dose.
- Experience in serving on project teams in early discovery is critical. Managing the ADME and PK screening paradigm in early lead optimization, as well as early phase 1 design and human PK predictions are minimum requirements.
- Clear track record of accomplishment (e.g. publications, patents, presentations) including evidence of leadership in managing DMPK core activities one or more internally discovered compounds into preclinical and/or clinical development.
- Recognized in the field of DMPK by both the pharmaceutical industry and the academic community.
- Excellent oral and written communication skills and an ability to interact and conduct strategic planning with colleagues in other scientific disciplines.
- In-depth knowledge of the overall drug discovery process and demonstrated ability to successfully direct efforts on multiple projects simultaneously.
- Software proficiency in Phoenix and/or Watson, GastroPlus is desired
- Experience in compiling and writing IND modules is desired
- Possesses scientific strategic thinking; decisions will result in critical effect on the Company's long-term success.
- 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.
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- 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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