Industry: Healthcare IT•
8 - 10 years
Posted 271 days ago
MD Anderson is known for providing cancer patients with exceptional care, which includes early access to innovative new treatments through clinical trials. The Institute for Applied Cancer Science (IACS) is a new hybrid model that uniquely combines the drug discovery capabilities of the biopharmaceutical industry and the extensive knowledge of biology found in academia with the expertise of MD Anderson's top clinicians. IACS has the singular goal of rapidly developing novel, effective and safe therapeutics that improve patient health. IACS executes programs with the highest probability of clinical success in a rigorous, goal-oriented, data-driven manner.
The Group Leader, Drug Metabolism and Pharmacokinetics Group will lead all aspects of the Drug Metabolism and Pharmacokinetics optimization of IACS small molecule oncology drug discovery programs, including the design and execution of a suitable screening funnel, issue-driven problem solving to resolve ADME/PK issues with the metabolism of lead molecules, liaising with the project teams in the selection of which molecule(s) to advance into development, the full characterization of those clinical candidates, and completion of the relevant sections of the IND-package.
The ideal candidate would have experience with in vitro ADME/PK, in vivo pharmacokinetics, analytical chemistry and regulatory environment.Experience with automated in vitro ADME and mass spectroscopy is required.
Salary Range: Min $148,500 - Mid $185,750 - Max $223,000
1. Lead the ADME/PK group within IACS to characterize and optimize the drug metabolism and pharmacokinetics of the lead small molecules in IACS’ oncology drug discovery program, coordinate ADME/PK and analytical efforts to deliver suitable compounds as preclinical candidates, and ultimately into clinical development.
2. Responsible for the development, validation, implementation and execution of a suitable ADME/PK screening funnel to support lead optimization small molecule drug discovery projects, to subsequently full characterize those clinical candidates, and when appropriate measure the human PK during phase I clinical trials.
3. Plan and implement novel ADME/PK strategies for multiple drug discovery programs. Formulates and executes innovative in vitro and in vivo DMPK studies that make major impact on the advancement of drug discovery projects.
4. Implement additional assays to resolve ADME/PK issues when they arise during programs, and to fully characterize mechanism of pharmacokinetics of lead compounds.
5. Coordinate, direct and lead a team of successful internal and external ADME/PK and analytical scientists.
6. Responsible for the development, optimization, validation, and implementation of ADME/PK assays to support target validation and lead optimization in small molecule drug discovery projects.
7. Monitor assay quality and data release and capture, troubleshoot issues with assay and instrument performance.
8. Contribute to project team through lab based activities.
9. Complete the necessary documentation for IND- and other regulatory filing, and for any due diligence/licensing activities.
10. Resource projects in a flexible manner, including efficient use of outsourcing.
11. Supervise, mentor and performance manage the ADME/PK team Stay abreast of technical developments in ADME/PK and analytical chemistry fields, and coordinate the application and development of cutting edge tools and methodologies to enable advancement of Institute projects.
12. Stay abreast of technical developments in ADME/PK and analytical chemistry fields, and coordinate the application and development of cutting edge tools and methodologies to enable advancement of Institute projects.
13. Interact closely with other in vivo pharmacologists, program biologists and with medicinal chemists on discovery-based project teams.
14. Critically evaluates and guides medicinal chemistry strategy to address ADME issues, conducts thorough analysis based on PK and in vitro ADME data, and provides clear guidance to project teams regarding specific SAR issues.
EducationRequired: PhD in one of the natural sciences or related field or Medical degree. Preferred: PhD in one of the natural sciences or related field or Medical degree, with significant component of analytical chemistry, drug metabolism and pharmacokinetics and/or mass spectroscopy.
ExperienceRequired: Nine years experience of relevant research experience in lab.
Preferred: Relevant industrial experience within the biotech/pharmaceutical industry. At least four years of relevant industrial experience within the pharmaceutical industry in an ADME/PK setting, trouble shooting pharmacokinetic and metabolism issues on a small molecule drug discovery program. Must have a broad understanding of the drug discovery process, and the requirements/characteristics of a molecule suitable to be advanced into clinical development.The ideal candidate would have experience with in vitro ADME/PK, in vivo pharmacokinetics, analytical chemistry and regulatory environment.Experience with automated in vitro ADME and mass spectroscopy is required.The position also requires strong data analysis skills, ability to interpret results and contribute to the design of follow-up experiments, troubleshoot issues with assay performance, and effectively present results and conclusions. Ability to work well under pressure and drive projects that affect critical timelines. Collaborative attitude is essential for this position.Experience also must include supervisory and leadership experience.