Job Description:

Principal Scientist

Clinical Pharmacology

Summary

Work in the Clinical Pharmacology & Drug Dynamics Group.

Duties and Responsibilities

PRIMARY JOB RESPONSIBILITIES:

* Independently plan and design nonclinical and clinical PK and PD studies
* Responsible for sample size estimation, statistical design and analyses of Phase I studies
* Contribute to the preparation of clinical study protocols and informed consents
* Work closely with Clinical Research Associates and be responsible for overseeing all aspects of study conduct including evaluation and selection of CRO, study initiation, monitoring, and close-out.
* Represent CPDD on Project Teams to raise and address nonclinical and clinical PK/PD, and metabolism related development issues.
* Participate in the preparation of regulatory submissions including Investigator Brochures, annual IND updates, INDs, NDAs, and sNDAs.
* Perform and interpret clinical and pre-clinical pharmacokinetic/toxicokinetic (PK/PD) analyses using compartmental and non-compartmental techniques; perform and interpret Pharmacodynamic (PD) analyses; establish PK/PD relationships
* Author technical reports ready for regulatory submissions
* Review intra- and inter-departmental as well as partner reports and documents
* Author manuscripts for publication in peer-reviewed journals
* Represent CPDD in corporate process Initiatives
* Participate in-licensing evaluations and due-diligence activities
* Independently propose and defend Clinical Development Plans for new projects
* Participate in Marketing sponsored Life-Cycle Management activities of projects
* Critically evaluate PK/PD data and provide recommendations to management on the necessary next steps to maximize efficacy and safety
* Participate in drug discovery efforts on an as needed basis
* Mentor scientists in CPDD

Requirements

Education: Ph.D. in Pharmacokinetics and Pharmacodynamics
Experience: 6+ years of postdoctoral and industrial experience
Knowledge, Skills and Abilities:
* Advanced PK/PD modeling, PK/PD software skills (WinNonlin, Kinetica, Clinical Trial Simulator and NONMEM)
* Advanced computer and software skills (MS Office, Sigma Plot, statistical programs).
* Excellent knowledge of GCP/ICH guidelines and FDA regulations and guidances
* Excellent understanding of the drug development process
* Excellent organizational and interpersonal skills
* Excellent verbal and written skills
* Excellent presentation skills
* Multidisciplinary collaborations