Senior Director, Clinical Pharmacology

Senior Director Of Clinical PharmacologyFor more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today.Corcept is headquartered in Redwood City, California.The Senior Director of Clinical Pharmacology contributes to the design and execution of the Clinical Pharmacology Development strategy for our small-molecule pipeline, and serves as a scientific bridge between research and development. This role will work closely with the Vice President of Clinical Pharmacology and Pharmacokinetics to develop pharmacokinetic and/or pharmacometric strategies to accelerate and support the overall product development, including securing drug approvals as well as advancing lead compounds into humans.Corcept operates a lean research and development model. The Senior Director of Clinical Pharmacology will lead a small internal team while also having individual contributor responsibilities. This is a hybrid role based at our Redwood City, California headquarters, typically requiring on-site presence at least three days per week.Responsibilities:Contributing to and implementing a comprehensive clinical pharmacology development strategy for our investigational compoundsDesigning and overseeing complex clinical pharmacology studies and/or assessments in healthy volunteers and in patientsServing as the departmental representative on project teams supporting nonclinical and clinical developmentProviding subject matter expertise in cross functional teams and collaborating with other team membersStrictly adhering to agreed timelines to ensure prompt and accurate execution of deliverablesAnalyzing, interpreting, and reporting nonclinical and clinical dataPlotting and evaluating animal and human pharmacokinetic dataReviewing and approving pharmacokinetic and/or toxicokinetic reportsReviewing and approving bioanalytical and method validation reportsUnderstanding, establishing, and integrating innovative tools and technologies to accelerate drug developmentAuthoring and owning the pharmacokinetic-related content of Investigator Brochures, study protocols, analysis plans, bioanalytical reports, and study reportsAuthoring, leading, and owning nonclinical and clinical pharmacokinetic-related documents for regulatory submissions, including INDs, NDAs, MAAs etcSupporting global regulatory interactions including preparing for and/or attending formal regulatory meetings, and responding to questions/requests from regulatorsManaging and mentoring direct and indirect reportsOverseeing and managing vendors and consultantsPreferred Skills, Qualifications and Technical Proficiencies: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 toolsHands-on and in-depth knowledge of current versions of PowerPoint and Word etcThorough understanding of current regulatory requirementsExcellent written and oral communication skillsProven ability to critically analyze problems, provide creative solutions, and influence senior leadersDiscipline and confidence to work in teams and to work independentlyPreferred Education and Experience:10-15 or more years of industry experience and a PhD, PharmD or MD degree with emphasis in pharmacokinetics, clinical pharmacology, or a related fieldThe pay range that the Company reasonably expects to pay for this headquarters-based position is $261,400 – $307,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.Applicants must be currently authorized to work in the United States on a full-time basis.Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.