Safety Medical Director

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. 

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 its founding in 1998.

Job Description

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, or 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.

Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol. 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.

We have gratitude and appreciation for the commitments and convictions of our employees who share a sense of responsibility to find better ways to improve patients’ lives.