Senior Director, Clinical Pharmacology

For 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. To learn more, visit www.corcept.com .

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 compounds

Designing and overseeing complex clinical pharmacology studies and/or assessments in healthy volunteers and in patients

Serving as the departmental representative on project teams supporting nonclinical and clinical development

Providing subject matter expertise in cross functional teams and collaborating with other team members

Strictly adhering to agreed timelines to ensure prompt and accurate execution of deliverables

Analyzing, interpreting, and reporting nonclinical and clinical data

Plotting and evaluating animal and human pharmacokinetic data

Reviewing and approving pharmacokinetic and/or toxicokinetic reports

Reviewing and approving bioanalytical and method validation reports

Understanding, establishing, and integrating innovative tools and technologies to accelerate drug development

Authoring and owning the pharmacokinetic-related content of Investigator Brochures, study protocols, analysis plans, bioanalytical reports, and study reports

Authoring, leading, and owning nonclinical and clinical pharmacokinetic-related documents for regulatory submissions, including INDs, NDAs, MAAs etc

Supporting global regulatory interactions including preparing for and/or attending formal regulatory meetings, and responding to questions/requests from regulators

Managing and mentoring direct and indirect reports

Overseeing and managing vendors and consultants

Preferred 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 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

Preferred 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 field

The 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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link .

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.

Please visit our website at: https://www.corcept.com/

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.