Clinical Research Director, Global Metabolism

Corcept is engaged in the discovery and development of drugs that treat severe endocrine, metabolic, oncologic and neurological disorders by modulating the effects of the hormone cortisol. Since 2012, we have marketed Korlym^® for the treatment of patients suffering from Cushing’s syndrome, a life-threatening orphan disorder caused by excess cortisol activity.

In addition to our commercial product, Korlym, we have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators.  Lead compounds are in Phase 2 and Phase 3 trials for the treatment of patients with Cushing’s syndrome, advanced ovarian cancer, castration-resistant prostate cancer, weight gain caused by antipsychotic medications and non-alcoholic steatohepatitis (“NASH”).  We are about to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (“ALS”).

In 2021, we generated revenue of $366 million and net income of $112 million.

Clinical Research Director, Global Metabolism

Clinical Research Director, Global Metabolism:

The Clinical Research Director will ensure the scientific integrity of clinical trials conducted by Company in the therapeutic area of Metabolism.

Responsibilities:

• Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
• Provide training and ongoing input to all members of the clinical team on scientific issues related to the therapeutic field in question
• Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
• Design, develop and, implement clinical studies for the applicable drug candidate
• Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
• Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
• Assists with safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
• Play a key role in the analysis, interpretation and delivery of high quality clinical data
• Interact with principal investigators and opinion leaders to facilitate clinical trials research
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, NDA/MAAs, throughout the development cycle
• Participate in clinical study report conceptualization, development and writing for global regulatory submissions
• Work closely and collaboratively with other functions, e.g. clinical operations, safety, translational science, research, biometrics, regulatory, medical writing, medical affairs and commercial pipeline strategy
• Serve as medical content reviewer for medical review committee (MRC)
• Develop and give internal and external presentations as subject matter expert for the therapeutic area
• Participate in the development and review of publications
• Prepare and monitor budgets in collaboration with clinical operations and R&D finance
• Participate in the management of human resources in a matrixed environment – recruitment, performance management, succession planning, talent management, etc.

Qualifications:

• Demonstrate strong clinical and scientific knowledge
• Are an excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
• Feel comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities

Requirements:

• MD, PharmD, or PhD with experience in Endocrinology preferable
• Requires at least 5 years of relevant clinical development experience
• Relevant basic and/or clinical research experience in academic settings is viewed favorably

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

If you are based in California, we encourage you to read this important information for California residents linked here.

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