Please message me to learn more about this role at a growing precision CNS
company:
Director or Sr. Director Level
This key position will work in multi-disciplinary teams as an expert in
Clinical Pharmacology & Clinical Pharmacokinetics to provide expertise and to
enable progression of compounds in development. The qualified candidate must
be able to apply advanced PK, PK/PD, and modeling & simulation to actively
address drug development related issues, and be able to design, analyze, and
interpret data from clinical studies.
The ideal candidate will provide input on clinical pharmacology profiling, dose
optimization, formulation bridging, and combination strategies to enable faster
and more effective drug development informed by core scientific principals and
data.
Responsibilities
* Independently contribute to compound development across various
development phases
* Be hands-on with analyses of data from Phase 1-3 studies including
non-parametric analyses, model based analyses, exposure-response relationship,
population PK modeling, simulations for different dosing regimen etc.
* Experience with PBPK and QSP is desirable
* Design healthy volunteer studies, write the protocol (working with
Medical Writers), propose any amendments to ensure optimum dataset is generated
from these studies
* Be an internal expert on clinical pharmacology guidelines and regulatory
expectations
* Write sections of the IND/IMPD as they relate to clinical pharmacology
plans or data summaries
* Participate in interactions with health authorities; serves as
Clinical Pharmacology subject matter expert
* High proficiency in PK, PK/PD, and model informed drug development
principles and analyses
Qualifications
* PhD in bio-engineering, pharmacokinetics, pharmaceutical sciences,
mathematics or statistics or related area with 7-10 years relevant biotech/
pharmaceutical experience.
* Industry experience working as a Clin Pharm project representative in
clinical projects. Expertise in PKPD modeling using NONMEM and or other
modeling, simulation and statistical tools.
* Advanced training in WinNonlin, WinNonmix, and NONMEM is required.
* Expertise in human PK and dose projection, and experience designing and
interpreting human PK/PD studies is a plus.
* Experience in bioanalytical, drug metabolism, transporter or formulation
areas is a plus
* Previous experience preparing and reviewing documentation to be included
in regulatory submittals.
* Experience working with Clinical CROs and phase 1 sites.
* Excel at working in a highly collaborative, team environment, and have
good organizational and communication skills.
TJ Elder
President
Pre-Clinical Development
O: 413.458.6124
C: 413.207.7676
https://www.linkedin.com/in/tjelder/
tel...@stem-sourcing.com<mailto:tel...@stem-sourcing.com>
[cid:image001.png@01D99D1C.E4B802D0]<http://www.stem-sourcing.com/>
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