Senior Principal Scientist, Pharmacokinetics, Dynamics and Metabolism Project Representative
Responsible for the oversight of a number of projects primarily within the ORU PDM group providing scientific leadership and strategic direction to assigned projects from idea to POC. Accountable for ADME optimization, PK predictions and ADME related development activities.
Works with bioanalytical and ADME scientists to ensure the appropriate experimental plans. Interfaces with the biomarker scientists, PK/PD modelers and Research unit partners to develop the translational pharmacology plan, PK predictions and dose projections for small molecule therapeutics. As PDM representative to the project team, he/she will synthesize the PDM knowledge, influence the preclinical project plans and optimization of the therapeutic. The candidate will also partner with other PDM scientific leaders to advance the ADME science and strategies for prosecuting primarily small molecule projects and may also influence external scientific and regulatory practices through publication and other interactions.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- PhD level education (or MS/BS with 10 or more years) in relevant field Industry experience in DM/PK and a strong record of scientific achievement & project influence.
- Experience in the preparation of regulatory applications (IND, NDA) and good knowledge of regulatory guidelines is highly desirable.
- Proven track record of influence projects and project teams, particularly in areas of emerging science.
- Experience integrating DM/PK discipline knowledge into broader project team to help guide project decisions.
- Extensive practical experience of project liaison and achieving results in a matrix environment.
- Experience in drug discovery / development up to POC Excellent presentation skills as demonstrated through internal and external presentations.
- Proven track record in the area of mentoring and coaching Skills:
- PK and disposition. Mechanistic modeling of pharmacokinetics (PK). SimCYP experience preferred.
- Broad understanding ADME and in vitro drug metabolizing enzyme and transporter assays.
- General knowledge of biotransformation and physical organic chemistry.
- Understanding of bioanalytical sciences generally by LC-MS/MS.
- General understanding of PK/PD modeling and its application to advance projects.
- Demonstrates ability to integrate data from multiple sources in to a rational understanding of drug disposition.
- Proficiency in human PK predictions.
- General understanding of drug discovery, chemistry and pharmacology- Oncology preferred.
- Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.
Other Job Details:
- Eligible for Relocation Package: yes
- Eligible for Employee Referral Bonus: yes
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