Senior Director, Clinical Pharmacology

Corcept Therapeutics•Redwood City, CA

1d•Hybrid

About The Position

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.

Requirements

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

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