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In this vital and exciting role, you will oversee Pharmacokinetics and Drug Metabolism (PKDM) activities at our upcoming research facility in India. This role involves interaction with various Amgen scientists supporting small molecule (SM) programs. You will also co-ordinate with local CROs involved in characterizing the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK) properties of SM therapeutic drug candidates.
Job Responsibility:
Lead/mentor a team of scientists involved in ADME characterization of small molecules
Directly responsible for leading a team of scientists involved in undertaking mechanistic in vitro ADME assays
Develop/implement novel tools to efficiently support mechanistic ADME work
Oversee activities/establish workflows for small molecule bioanalytical and ADME screening teams
Serving as a subject matter expert of small molecule ADME to support the programs and recommend strategies to PKDM project team representatives to reduce/mitigate risks due to metabolism
Collaborate with scientists across our PKDM scientific community
Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, to impact project progression and decision-making
Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
Building close relationships with partner functions
Requirements:
PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 12+ years of experience in the Biotechnology/Pharmaceutical Industry
Solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
Ability to drive the progression of SM discovery and development within project teams
Expertise with in vitro ADME, in vivo ADME, PK/PD etc
Experience in supporting preclinical components of regulatory documentations
Excellent interpersonal, technical, and communication skills
Past experience as a laboratory scientist in a pharma or biotech environment
Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
Record of scientific contributions through peer-reviewed articles and external presentations
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