Safety Medical Director

Location
Menlo Park, CA
Posted
May 20, 2022
Ref
4364986004
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.

Safety Medical Director

Serve as the safety expert accountable for assigned Corcept products (investigational and marketed). Responsible for developing a safety plan and its execution, e.g., medical assessment of individual safety events, signal detection, benefit-risk evaluation, and appropriate risk management activities. Contribute to pharmacovigilance (PV) inspection and audits, and continuous process improvement.

Responsibilities:

  • Responsible for medical review of serious safety events from clinical trials and spontaneous and solicited post-marketing reports for assigned programs.
  • Develop a product-specific Safety Plan. Perform safety data monitoring, analysis, and interpretation. Maintain good documentation. Communicate safety profile effectively (written and verbal) both internally and externally.
  • Provide safety input to clinical study protocols, investigator’s brochures, clinical study reports, statistical analysis plans, and similar documents requiring significant safety sections. Ensure consistent presentation of safety and risk management topics across various regulatory documents.
  • When required, develop safety sections of a regulatory package (NDA, Briefing Document, Orphan Drug Application). Respond to health authority queries.
  • Enhance safety data quality and data integrity across clinical trials.
  • Prepare and review aggregate safety reports including Periodic Adverse Drug Experience Reports (PADERs), and Development Safety Update Reports (DSURs).
  • Support PV vendor oversight, continuous process improvement, and inspections and audits.

Preferred Skills, Qualifications and Technical Proficiencies:

  • Ability to work in a dynamic environment to meet corporate and patient needs.
  • Working knowledge of Argus (or similar applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries.
  • Excellent communication and collaboration skills.
  • Demonstrated success in taking the initiative in a team setting. Comfortable with ambiguity yet be self-motivated and timeline driven.

Preferred Education and Experience:

  • MD or international equivalent. Advanced training in oncology, endocrinology, metabolism, pharmacology, epidemiology, or other relevant specialties is a plus.
  • Minimum 4 years safety and PV experience including a focus in post-approval setting, plus 2 years drug development experience. Other relevant experience may be considered.
  • Experience with NDA filing is a plus.

    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