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.
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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.
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