Senior Director, Clinical Pharmacology

The role

The Senior Director of Clinical Pharmacology contributes to the design and execution of the Clinical Pharmacology Development strategy for the small-molecule pipeline. This person will lead a small internal team and serve as a scientific bridge between research and development.

What you will do

• Contributing to and implementing a comprehensive clinical pharmacology development strategy
• Designing and overseeing complex clinical pharmacology studies in healthy volunteers and patients
• Serving as the departmental representative on project teams
• Providing subject matter expertise in cross functional teams
• Analyzing, interpreting, and reporting nonclinical and clinical data
• Plotting and evaluating animal and human pharmacokinetic data
• Reviewing and approving pharmacokinetic, toxicokinetic, bioanalytical and method validation reports
• Authoring pharmacokinetic-related content for Investigator Brochures, study protocols, and analysis plans
• Authoring nonclinical and clinical pharmacokinetic-related documents for regulatory submissions
• Supporting global regulatory interactions and managing vendors and consultants

Required qualifications

• Applicants must be currently authorized to work in the United States on a full-time basis

Nice to have

• Hands-on and in-depth knowledge of current versions of data analysis software such as Excel, GraphPad, WinNonlin, Monolix, NONMEM, R and/or other pharmacokinetic/pharmacometrics tools
• Hands-on and in-depth knowledge of current versions of PowerPoint and Word etc
• Thorough understanding of current regulatory requirements
• Excellent written and oral communication skills
• Proven ability to critically analyze problems, provide creative solutions, and influence senior leaders
• Discipline and confidence to work in teams and to work independently
• 10-15 or more years of industry experience
• PhD, PharmD or MD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related field

About the company

Corcept is focused on the science of cortisol. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists.