My client is a rapidly growing biotech company with an exciting pipeline of
small and large molecules within oncology and is looking for quantitatively
oriented clinical pharmacologists.
Manager-Associate Director, Clinical Pharmacology
The Manager-Associate Director, Clinical Pharmacology (CP) functions as the
Clinical Pharmacology (CP) team representative at the Product Strategy Team for
small molecule and biotherapeutics in Phase 1-3 of clinical development and is
responsible for all aspects of clinical pharmacology-related support for
candidates. This includes design and execution of clinical pharmacology
studies, design of clinical pharmacology portion of other clinical studies,
analysis and reporting of data, communication of results and strategy to
project teams, and communication of data and analysis reports in regulatory
documents and meetings. This position will report into one of the Senior
Directors within the department of Clinical Pharmacology and Pharmacometrics.
Title commensurate with the number of years of relevant experience.
Essential Functions:
* In collaboration with CP leadership, develop CP strategy and
short/long-term plans for projects at all stages of clinical development - IND
to NDA/BLA. Communicate these strategies at internal and external meetings
* In collaboration with CP leadership, design, conduct, analyze, interpret,
and communicate results from CP studies with guidance
* Perform hands-on analyses of data using noncompartmental methods and
population PKPD modeling and simulation methodologies and disseminate the
relevant risk/benefit implications to project development teams.
* In collaboration with CP leadership, develop and execute the regulatory
strategy (e.g end of phase 1/2 meetings, Type C meetings, and NDA/BLA
discussions)
* Collaborate with Biostatistics, Clinical Research, Clinical Operation,
and Drug Metabolism colleagues for the appropriate design of Phase I-III studies
* Contribute to the preparation of key documents including investigators
brochures, clinical study protocols, study reports, and regulatory briefing
documents.
* As a lean but growing department, contribute to the establishment of best
practices for CP activities - e.g. draft department SOPs, establish quality
systems, create plan/report templates, etc.
Education & Experience:
* An advanced degree in Pharmaceutics/Pharmacy/Engineering/Statistics with
demonstrated expertise in quantitative PKPD skills.
* Basic understanding of drug development.
* Expertise with standard modelling and simulation software (NONMEM,
S-Plus/R, etc) is required. Expertise in other modelling software (e.g.
GastroPlus, SimCYP, MATLAB, Berkeley-Madonna, etc.) is highly desirable.
* Experience of active and effective communication with cross-functional
project teams.
* Good oral and written communication skills as shown by a publication
track record
Other Information
* Position level and title will be commensurate with experience
* Position may require occasional evening and/or weekend commitment
* Position may require occasional travel (~15%), domestic and international.
________________________________
K. David Cadieu KDC GROUP, INC.
239-564-4554 [email protected]<mailto:[email protected]>