Job Description

Career Category Research

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. In this role, your core responsibilities include:

• 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

Preferred Qualifications:

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 12+ years of experience in the Biotechnology/Pharmaceutical Industry
• Candidate should have 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
• Establish SM ADME worklows for PKDM scientists.
• 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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Skills Required