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Iambic Therapeutics, a clinical-stage AI-driven drug discovery and development company based in San Diego, is seeking an Associate Director, Drug Safety to join its Safety team. Reporting to the Head of Safety, you will oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables across all phases of development for oral small-molecule oncology therapies.
You will work collaboratively with Quality, Clinical Operations, and Clinical Development to establish and execute safety processes in a dynamic, growing organization. The role offers flexibility and may be based at the San Diego headquarters or remote.
Key responsibilities include:
**Case Processing & Vendor Oversight:** Provide day-to-day oversight of SAE (Serious Adverse Event) processing activities performed internally and externally. Coordinate reconciliation of safety information across clinical databases and business partners. Monitor vendor performance through compliance trends and operational deliverables, tracking action items, issues, and corrective actions. Support implementation, maintenance, and enhancement of safety databases.
**Safety Science Support:** Contribute to aggregate safety reports and safety sections of clinical, safety, and regulatory documents. Coordinate safety data deliverables for aggregate reports, regulatory submissions, and health authority requests. Review individual and aggregate safety data to identify emerging trends.
**PV Quality, Compliance & Inspection Readiness:** Co-author and maintain controlled documents, Safety Management Plans, Safety Data Exchange Agreements, and other inspection-readiness documentation. Support CAPAs (Corrective and Preventive Actions), change controls, audits, and regulatory inspections.
Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets to address unmet patient needs, with demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed.
**Requirements:**
- Bachelor's degree in nursing or pharmacy; advanced degree (PharmD, MSN, MPH) or equivalent preferred
- At least 10 years of combined experience in pharmacovigilance, drug safety, clinical science, or related field (or 6–8 years with an advanced degree)
- Related experience across both safety science/surveillance and pharmacovigilance operations preferred
- Strong understanding of MedDRA and WHODrug dictionaries
- Proficiency in Safety Databases
- Excellent interpersonal skills and professionalism
- Written and verbal proficiency; ability to communicate clinical topics succinctly and clearly
- Ability to train, mentor junior Drug Safety staff, contractors, consultants, and vendor personnel
- Knowledge of applicable global pharmacovigilance regulations and guidance (FDA, EMA, ICH, GCP, GVP requirements)
- Oncology phase I–III experience preferred
