Job Category: Engineering & Chemistry

Dir. Quantitative Clin. Pharmacology (MGM)

Job Location: Greater San Diego Area, CA

Director, Quantitative Clinical Pharmacology

RESPONSIBILITIES:
Work as part of the clinical pharmacology/pharmacometrics team and in collaboration and interaction with other functions in multiple clinical development programs. Contribute to and implement an overall nonclinical and clinical PK/PD development strategy to support all stages of drug development. Prepare study synopses, protocols, study reports and regulatory documents to support the clinical and nonclinical pharmacology development. Implement and advance PK/PD modeling and simulation approaches focusing on immuno-oncology therapies. Play a key role in managing studies PK operations with CROs and contracted vendors and proactively providing technical input on quantitative issues. Contribute with project teams/partners to all regulatory documents including Investigator Brochures, EOP2 meetings, IND/NDA/IMPDs/sNDAs.

REQUIREMENTS:
Pharm.D and/or PhD degree with training and/or expertise in one or more areas related to pharmacometrics, clinical pharmacology or preclinical ADME studies. 7+ years of industry or consulting experience working in R&D, pre-clinical and or clinical environments. Experience in pharmacometrics, clinical pharmacology, pharmacokinetics, model-Based Drug Development in a project team setting in academia or industry. Experience with PK/PD modelling with strong quantitative skills. Broad translational and clinical development expertise with emphasis on Pharmacometrics. Advanced user of modelling software such as WinNonlin Phoenix, NONMEM, S-Plus/R.

Please contact Manja Molan at mmolan@clarkdavis.com

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