Safety Medical Director

Menlo Park, California
Dec 01, 2021
Biotech Bay
Required Education
Position Type
Full time

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.

Essential Duties/Tasks
  • 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 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.
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.

Position Location – Must be located in the North California/Bay Area.  Out of state applications will only be considered if you have indicated that you are willing to relocate to the Northern California/Bay Area.