Senior Safety Medical Director, Endocrinology and Metabolism

Location
Menlo Park, CA
Posted
Sep 24, 2021
Ref
1107
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Serve as a senior scientific and clinical safety expert accountable for assigned Corcept Therapeutic areas (investigational and marketed). Defines global product safety strategy, manages and leads functional and cross-functional projects to enable signal detection, benefit-risk evaluation, and appropriate risk management activities. Contribute to pharmacovigilance (PV) inspection and audits, and continuous process improvement.

Responsibilities
  • Lead therapeutic area safety strategy development and execution
  • Oversee all aspects of safety pertaining to medical reviews of serious safety events, on-going safety data monitoring, analysis, and review
  • Communicate safety profile and safety decisions effectively (written and verbal) both internally and externally. Respond to health authority queries.
  • Embed safety risk management strategies in clinical study protocols, investigator’s brochures, clinical study reports, statistical analysis plans, and similar documents. 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).
  • Establish and approve scientific methods used to evaluate safety. 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).
  • Provide strategic input to the organization to mitigate pharmacovigilance-related risks.
  • 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 8 years drug development experience; of which, 5 years directly working on safety and pharmacovigilance PV. Other equivalent experience may be considered.
  • Deep knowledge in drug development regulations. 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.