Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
- Serve as the leader of the DM-NCPK In Vitro Assay Group. Manage a team of high-performing bench level ADME scientists in support of discovery and development programs and oversee all aspects of in vitro assay suite instrumentation, experimental design, data generation/integration/translation/reporting. In addition, oversee CRO partner-enabled activities as needed
- Represent DM-NCPK as a key opinion leader in discovery working group and development teams, as well as contribute to the strategy for compound advancement.
- Develop interdisciplinary collaborations and ensure that key in vitro data, information, and priorities are integrated into overall team strategy and have impact on compound selection.
- Responsible for the design and interpretation of in vitro studies necessary for the selection of clinical candidates including adequate liability assessment.
- Responsible for data integrity and ensuring in vitro data reports are of the highest standard. In addition, review/manage the relevant sections for regulatory submissions and IB updates consistent with corporate timelines.
- Effectively present data and recommendations to discovery and development teams, external collaborators, and senior management; includes interfacing with DM-NCPK colleague project representatives during data integration/review meetings.
- Evaluate process and new technology keeping DM-NCPK at industry standards.
- As needed, able to serve as DM-NCPK project representative on select discovery working groups.
- Track the literature and publish in peer reviewed journals; includes attendance of external scientific meetings.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- PhD or equivalent with a minimum of 12 years of industry experience in DMPK.
- In-depth understanding of in vitro and in vivo PK-ADME studies and track record of designing and implementing DMPK studies to impact discovery and/or development programs.
- Broad knowledge of both drug transporter and drug-metabolizing enzyme science, includes but not limited to victim/perpetrator DDI.
- Proven record of developing, validating, and implementing in vitro DMPK assays in support of portfolios.
- Track record of conducting various IVIVE exercises using static models; experience developing and validating PBPK models to predict/describe compound DDI, PK and disposition.
- Expertise deploying in silico ADME predictor tools to support SAR is desirable.
- Excellent oral and written communication skills and strong organizational skills.
- Prior experience managing/mentoring a group of scientists.
- Experience working in a matrix environment; flexibility supporting fast-paced discovery/medicinal chemistry campaigns as well as clinical/agency-focused programs.
- Appropriate publication record is desirable.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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