Vice President, Drug Safety

Location
Menlo Park, CA
Posted
May 21, 2022
Ref
4466309004
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

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.

Vice President, Drug Safety

 The Position:

We are looking for a Vice President, Drug Safety who is experienced, creative and collegial with the technical and managerial skill to lead the skilled professionals responsible for collecting, interpreting and reporting the safety data arising from our expanding clinical and commercial activities.

Safety is fundamental to Corcept’s mission.  The Vice President, Drug Safety will report to our Chief Business Officer and will interact regularly with the Chief Development Officer, Chief Scientific Officer and Chief Executive Officer.

Responsibilities:

The leader of our drug safety effort is responsible for ensuring that we gather, catalog, analyze and report the safety events arising from our clinical and commercial activities and continue to build an industry-leading safety group with best-in-class personnel and supporting infrastructure. 

Doing this well requires:

  • working closely with members of Corcept’s safety, clinical development and regulatory teams, as well as with independent consultants and pharmacovigilance vendors;
  • managing the safety aspects of Corcept’s interactions with the FDA and other regulators, including both regularly required reporting and our response to ad-hoc inquires, inspection-readiness activities and NDA-related work;
  • collaborating with our development groups as we advance compounds towards approval, with an eye to investigator brochure and eventual drug labeling and post-approval reporting requirements;
  • building the managerial, procedural and systems infrastructure needed to support our activities;
  • recruiting and hiring new team members and helping develop the careers of our current team; and
  • working with the Chief Business Officer to chart the safety team’s strategic direction and central role in the company.

Preferred Skills, Qualifications and Technical Proficiencies:

  • Experience reviewing and reporting of adverse events arising in the setting of complex disease and multi-medication treatment regimens
  • Ability to coordinate the activities of employees of different groups within Corcept as well as third party consultants, vendors and regulatory authorities.

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 with at least three years in drug safety
  • Five plus years senior management experience
  • Demonstrated ability to analyze reports of serious adverse events, identify significant facts and report them internally and to regulators
  • Excellent verbal/written communication skills
  • The ability to work collegially.

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.

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