Please message me to learn more about this role at a growing precision oncology
company:
Senior Director of Quantitative Pharmacology reports to the Head of Clinical
Pharmacology and Toxicology and serves as an integral contributor to all the
preclinical and clinical development projects at Company.
Job duties & responsibilities:
* Partner with Head of Clinical Pharmacology and Toxicology,
Program Team leaders and R&D staff to lead the pharmacometrics and quantitative
PK/PD strategy for Company's discovery and development programs
* As a member of the Company's project teams, the individual will
be responsible for applying model-based approaches to support compartmental and
mechanism-based PK/PD analysis, evaluation of FIH dose and regimen
recommendations.
* Develop and execute strategies for mid-stage and late-stage
Oncology programs to support regulatory questions and filings
* Provide due-diligence and strategic regulatory advice/evaluations
for oncology drug development programs
* The successful incumbent will utilize a range of computational
approaches (PK/PD, PBPK, pharmacometrics, systems-based, informatics). The
scope of project responsibility will range from late discovery through
registration.
Required knowledge, skills, and experience:
* A Ph.D. in Pharmacology, Biology, Engineering, Mathematics or
related field with 10+ years of relevant experience in modeling and simulation.
* Excellent understanding of PK (NCA, compartmental) and PK/PD
principles.
* Expertise in the application of Phoenix WinNonlin, PBPK related
software, and R is required.
* Experience with pharmacometrics with regulatory reporting is a
plus.
* Superior communication skills (both written and oral) and
attention to detail
* Strong organizational skills
* Leads by example and highly collaborative with the proven ability
to work in a cross-functional internal and external teams
* Must be able to prioritize work effectively to ensure progression
of multiple department and corporate timelines
* Pro-active in identifying opportunities along with strong problem
solving and negotiation skills
* A strategic thinker who can generate ideas and opportunities and
turn them into successful results
Benefits:
* Competitive salary, bonus and stock options
* Comprehensive health benefits
* Flexible work schedule
* A fun place to work and make an impact in patients' lives
TJ Elder
President
Pre-Clinical Development
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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