JOB SUMMARY
We are hiring an Associate Director, Drug Safety to join our Safety team at Iambic Therapeutics. Reporting to the Head of Safety, the Associate Director will oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables. The Associate Director will work collaboratively with Quality, Clinical operations, and Clinical development to set up and execute safety processes. A successful candidate will have flexibility in our dynamic and growing organization. The Associate Director will have responsibilities across all phases of development for our oral small-molecule oncology therapies.
The position may be based in our San Diego headquarters or remote.
KEY RESPONSIBILITIES
Case processing and vendor oversight
- 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. Tracking of actions items, issues, corrective actions.
- Support implementation, maintenance, and enhancement of safety databases as applicable.
Safety Science Support
- Contribute to aggregate safety reports, safety sections of clinical, safety and regulatory documents as requested.
- Coordinate safety data deliverables for aggregate reports, regulatory submissions, and health authority requests.
- Review individual and aggregate safety data and identify emerging trends.
PV Quality, Compliance & Inspection Readiness
- Co-author and maintain controlled documents, Safety Management Plans, Safety Data Exchange Agreements, and other documents needed to ensure inspection readiness.
- Support CAPAs, change controls, audits, and regulatory inspections.
QUALIFICATIONS
- Bachelor's degree in nursing or pharmacy; advanced degree such as PharmD, MSN, MPH, or equivalent preferred.
- At least 10 years of combined experience in pharmacovigilance, drug safety, clinical science, or a related environment with a Bachelor's degree and 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 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.
- Oncology phase I to III experience preferred.
PAY AND BENEFITS
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
