Associate Director, Clinical Pharmacology - Boston
Associate Director, Clinical Pharmacology
The Associate Director, Clinical Pharmacology is responsible for providing
critical information regarding the definition of lead candidate attributes
in humans including the determination of PK and PD properties, appropriate
dose selection, drug interaction risk, pharmacogenetic and demographic
influences, and product attributes relative to emerging and existing
competition. By integrating the knowledge of PK, PD, pharmacogenetics
(PGx), demographics and disease, the individual will support the team in
making informed decisions regarding the advancement, successful development,
and registration of new therapeutic agents.
* Responsible for providing clinical pharmacology components of the
Clinical Development Plan and providing clinical pharmacology input to the
clinical and project teams.
*
Design clinical pharmacology studies that yield high value PK/PD/PGx insight
for future critical decisions.
*
Analyze PK/PD data and interpret results with respect to their impact on the
advancement and development of new therapeutic agents.
*
Work with Clinician, Statistician, and/or Pharmacometrician on the
appropriate dose-finding strategies to ensure optimal dosing regimen(s) for
patients and registration.
*
Work with study and program teams to achieve program goals and provide
deliverables in approved timeframes.
*
Identifies program and study-specific issues. Generates potential solutions
to issues and proposes those solutions to management and/or study teams.
*
Utilize Advisory Board members, thought leaders, and academic collaborators
as necessary to add effective value to development programs.
*
Maintains strong knowledge of best regulatory practices, analytical
technology and drug development precedent.
*
Provides insightful regulatory strategy for drug filings and is responsible
for Clinical Pharmacology sections of regulatory documents
Call or email me for full details.
Dave
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K. David Cadieu KDC GROUP, INC.
609.882.8660 <mailto:[email protected]>
[email protected]