Our client is growing rapidly!  This newly created position will report to the 
Head of Quantitative Pharmacology

Position Summary
strategic and scientific job, responsible for quality of modeling work being 
performed.  This person will apply state of the art modeling and simulation 
(M&S) approaches to influence designs and internal/external decision making 
across the portfolio. We expect this person to develop and apply quantitative 
frameworks that enable model-informed drug discovery and development. In 
addition, this position will ensure quantitative rigor and quality results 
through direct scientific mentorship


JOB DUTIES
- Accountable for developing a culture encouraging approaches influencing key 
partners, stakeholders and regulators of its value and application

- Accountable for planning and executing state-of-the-art M&S techniques with 
direct value for projects cross the portfolio

- Scientific and strategic input into pre-clinical, clinical, and post-approval 
development plans

- Accountable for oversight, support and delivery of scientific and strategic 
modeling work related to specific projects

- Support evaluation of drug candidates for in/out-licensing

- Accountable for the identification and development of drug-disease models and 
other modeling approaches to support internal and external decision making in 
collaboration with partners (when relevant)

- Accountable to provide peer review and mentoring of junior staff

- Support and contribute to the development of the quantitative pharmacology in 
terms of providing training and knowledge sharing

- Monitoring external and internal environment in terms of relevant new 
methodologies and applications

- Increase profile externally in the area by speaking at external events and by 
publication in recognized external journals

- Ensure modeling efforts are aligned with current regulatory expectation

- Partner with the Preclinical Pharmacokinetic/Pharmacodynamics Team to enable 
translational PKPD efforts in the Discovery space


REQUIREMENTS
Education

This position requires a PhD in Pharmaceutical Sciences (PKPD emphasis), 
Statistics, Engineering or other quantitative subject areas. 15 years validated 
experience in the application of QP in a drug discovery/development setting 
including experience in developing PhD modelers is required. This experience 
should include noteworthy expertise in M&S, including PK, PKPD and Statistics. 
Broad Translational and Clinical development expertise in drug development 
(early and late), with emphasis on Pharmacometrics is required.

The candidate will have an international reputation gained from publishing in 
the field on Pharmacometrics as well as a track record of identifying, 
developing and executing portfolio-level M&S activities and disease domain 
knowledge.

A confirmed knowledge of Regulatory, compliance, processes, standards and 
Pharmacometrics issues as well as Regulatory experience (written/oral) is 
desired.

For more information please contact:

TJ Elder
President
Clinical Pharmacology / Pharmacometrics
O: 413.458.6124
C: 413.207.7676
https://www.linkedin.com/in/tjelder/
tel...@stem-sourcing.com<mailto:tel...@stem-sourcing.com>


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