Vice President, Regulatory Affairs
- Corcept Therapeutics
- Menlo Park, CA
- Start date
- Mar 25, 2023
- Regulatory, Regulatory Affairs
- Required Education
- Position Type
- Full time
- Biotech Bay
Corcept is a commercial-stage company engaged in the discovery and development of drugs to 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 2022, we generated revenue of $402 million and net income of $101 million.
We have discovered a portfolio of more than 1,000 proprietary selective cortisol modulators. Our 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 and amyotrophic lateral sclerosis (“ALS”). We plan to initiate a Phase 2b trial in patients with non-alcoholic steatohepatitis (“NASH”) by the end of this year. Every year, we advance new molecules to the clinic.
Over the next few years, we expect to submit several new drug applications.
We are looking for a Vice President, Regulatory Affairs with the creativity and judgment to craft and implement our regulatory strategy and the managerial skill to lead the diverse team of professionals responsible for drafting and submitting our regulatory filings.
Corcept has reached an inflection point: At present we have one approved medication – Korlym – which we distribute in the United States. As our clinical programs continue to mature, we expect to seek approvals for new medications to treat a variety of indications and to expand our commercial activities to international markets. Handling regulatory matters with wisdom and shrewdness will be key to our success.
The Vice President, Regulatory Affairs will report to our Chief Business Officer and will interact regularly with all of our C-level executives.
Performing Well Will Require:
- Working closely with members of Corcept’s safety, clinical development and commercial teams;
- Collaborating with our development groups as we advance compounds towards approval, with an eye to eventual drug labeling and post-approval reporting requirements;
- Building the managerial, procedural and systems infrastructure needed to support our growth;
- Recruiting and hiring new team members and helping develop the careers of our current team; and
- Working with the Chief Business Officer to optimize Regulatory Affairs contributions to our success.
Preferred Skills, Qualifications and Technical Proficiencies:
- Experience managing the regulatory aspects of drug development from pre-clinical research through NDA submission and review;
- Ability to coordinate the activities of different groups within Corcept as well as third party consultants, vendors and regulatory authorities;
- Ability to speak and write clearly and concisely
- A collegial working style.
Preferred Education and Experience:
- US or non-US medical degree; PharmD or nurse practitioner credentials with substantial drug safety and management experience;
- Ten or more years drug company experience, including work on one or more NDAs; and
- Five plus years senior management experience.
The pay range that the Company reasonably expects to pay for this position is $320,000 - $380,000; the pay ultimately offered may vary based on legitimate considerations, including job-related knowledge, skills, experience, and education. An annual cash bonus and equity grants may be provided as part of the overall compensation package, in addition to a full range of medical, financial, and/or other wellness benefits, dependent on the position offered.
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
Corcept is leading the discovery and development of drugs that modulate the effects of cortisol.
Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases. Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since being founded in 1998.
Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity. To support this mission, Corcept collaborates with numerous basic scientists and clinical researchers to find better ways to improve patient lives.
Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases driven by cortisol dysregulation.
Stock Symbol: CORT
149 Commonwealth Drive
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.Create alert