Associate Director, Drug Safety

The role

The Associate Director will oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables. This role involves working across all development phases for oral small-molecule oncology therapies.

What you will do

• Provide day-to-day oversight of SAE processing activities performed internally and externally.
• Coordinate reconciliation of safety information across clinical databases and business partners.
• Monitor vendor performance through compliance trends and review of operational deliverables.
• Track action items, issues, and corrective actions.
• Support implementation, maintenance, and enhancement of safety databases.
• 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 and identify emerging trends.
• Co-author and maintain controlled documents, Safety Management Plans, and Safety Data Exchange Agreements.
• Support CAPAs, change controls, audits, and regulatory inspections.

Required qualifications

• Bachelor's degree in nursing or pharmacy
• At least 10 years of combined experience in pharmacovigilance, drug safety, clinical science, or a related environment with a Bachelor’s degree
• 6-8 years with an advanced degree
• Strong understanding of MedDRA and WHODrug dictionaries
• Proficiency in the use of Safety Databases
• Excellent interpersonal skills and professionalism
• Written and verbal proficiency with 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, including FDA, EMA, ICH, GCP, and GVP requirements

Nice to have

• Advanced degree such as PharmD, MSN, MPH, or equivalent
• Related experience across both safety science/surveillance and pharmacovigilance operations
• Oncology phase I to III experience

Benefits

• Company-paid medical coverage
• Flexible spending accounts
• Voluntary life insurance
• 401(k) matching
• Flexible time off
• Community gym
• Dining

About the company

Iambic Therapeutics (Nasdaq: IAM) is a technology and clinical-stage life sciences company headquartered in San Diego. The company utilizes molecular superintelligence to address the totality of drug discovery and development.