This individual will lead the drug metabolism, enzymology and transporter team within DMPK at Takeda Boston site. Specific responsibilities will include:
- Provide strategic vision and leadership to the Enzymology/Transporter group for planning and execution of high quality in vitro DDI studies to understand and quantify the biotransformation routes, enzymatic pathways (CYP, non-CYP, UGT, etc) and role of transporters involved in metabolism and disposition, and identify potential liabilities for induction and inhibition of metabolism and transport of co-administered drugs. Write comprehensive reports in support of IND/NDA submissions.
- Provide DMPK leadership in support of clinical DDI study design and interpretation of DDI findings based on the phenotyping data, clearance pathways/mechanisms and alteration of drug-transporter activities in humans.
- Supervise, mentor and develop multiple scientists and manage CRO activities for outsourced DDI-related work.
- Proactively engage with emerging technologies, participate in consortia for investigation of evolving technologies, and conduct research to improve capabilities and understanding of clearance, metabolism and transport of drugs.
QUALIFICATIONS FOR JOB (Knowledge, Skills, Abilities, Effectiveness, Collaboration and Leadership):
- Hands-on laboratory experience in the evaluation of all aspects of enzymology and/or role of transporters is required. Expertise in LC/MS instrumentation and experience with developing LC/MS/MS methods for the determination of 1) reversible inhibition, TDI, induction potential of P450 enzymes and 2) substrate/inhibition potential of transporters is desirable.
- Strong knowledge of clinical relevance of clearance mechanism, metabolic pathways, enzymology, drug transport across multiple organs and regulatory guidances on DDI is required. Additional experience, knowledge and expertise in the following areas are a plus:
- Writing/reviewing ADME reports for regulatory submission
- Ability to work independently and having excellent written and oral communication skills.
- DMPK project representative in discovery and development teams.
- Proven track record in insightful publications contributing to of all aspects of enzymology and transporter related works.
Requirements for Job (Years of experience, Education, Certifications):
Ph.D. in Analytical Chemistry, Pharmacology and/or Pharmaceutical Sciences with a minimum of 8 years of hands-on experience with the assessment role enzymes and transporters in the disposition of drugs and metabolites using LC/MS/MS techniques is required. MS candidates with a minimum of 12 years of experience may be considered. Experience in supervising scientists and associates and a good track record of publications on determination of phenotypes, reversible and time-dependent inhibition and induction, and substrate and inhibition potential of transporters. The candidate must be a team player with excellent communication/interpersonal skills. Proven ability to work independently and handle effectively multiple projects is must.
Please send your CV to:
Drug Metabolism Department
Takeda Pharmaceuticals Int. Co.
35 Landsdowne Street
Cambridge, MA 02139
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