Sr. Director Quantitative Pharmacology / Pharmacometrics-Cambridge Massachusetts
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/
[email protected]<mailto:[email protected]>
[cid:[email http://www.stem-sourcing.com/
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