The individual will support all phases of drug development and program design by providing specialized guidance and direction regarding all aspects of Clinical Pharmacology.  As a senior contributor to the clinical department, is accountable for and may oversee the development and recommendation of novel clinical study designs and clinical strategies.  This individual will lead design of novel clinical study designs and clinical strategies for determination PK, DDI, PK/PD and POP/PK for respective compounds and ensuring quality, timely, and cost-effective project deliveries.

The successful candidate will have the ability to integrate clinical and non-clinical considerations for drug metabolism, pharmacometrics, and toxicology data to assist in the development of the clinical pharmacology strategy of VIVUS compounds. The candidate will work to advance multiple compounds by integrating PK/PD and clinical data to evaluate/simulate optimal doses/regimens, exposure-response, exposure-safety analyses, etc. to support the clinical pharmacology section of product inserts.

        Posititon Requirements

• Provide expert Clinical Pharmacology advice in all programs. 
• Design and write clinical PK protocol synopses, PK analysis plans, study reports, and Clinical Pharmacology sections of regulatory submissions.
• Able to work independently to analyze, interpret and apply new clinical data to refine the PK development plan.
• Ability to assess results from standard PK software (e.g., WinNonlin, NONMEM), proficiency in the use of such programs in not required.
• Actively participate in cross-functional and clinical teams by promoting clinical pharmacology, explaining/defending the PK strategy and data analyses, and providing PK deliverables according to timelines.
• Draft, contribute to, and review presentations for professional meetings hosted by VIVUS. 
• Vendor management with CRO and other parties to oversee design development and execution of studies
  

       Requirements

• PhD, MS, PharmD degree in pharmaceutics, pharmacology, pharmacokinetics,. 
• Must have a comprehensive understanding of principals of clinical pharmacokinetics and pharmacodynamics from at least 5-10 years of clinical pharmacology/pharmacokinetic drug development and data analysis experience in a CRO or clinical group of a pharmaceutical company. 
• Excellent oral and written communication skills required.
• Understanding of Good Clinical Practice.
• Demonstrated ability to work effectively with people and to lead teams is essential.
• Ability to collaborate with cross-functional and external teams.

 To apply for this position please use the link above "Apply Here" and attach your resume in a MS Word or PDF format.  Please include a brief cover letter summarizing your relevant experience, and note the job title in the subject line of the email