Associate Director, Drug Safety

JOB SUMMARY

We are hiring an Associate Director, Drug Safety to join our Safety team at the company. 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.

ABOUT the company

The company (Nasdaq: IAM) is a technology and clinical-stage life sciences company headquartered in San Diego. By utilizing molecular superintelligence — integrating proprietary AI with automated, scalable chemistry and biology experimentation — our platform is designed to address the totality of drug discovery and development. At the company, we are building an engine that is designed to power the future of medicine. Learn more at the company.ai [link for members]

MISSION & VALUES

Our mission is to make better technology for better medicines. Three values guide how we work:

• Bold. We are courageous, take thoughtful risks, and approach challenges with tenacity.

• Innovative. We are creative and find new solutions that deliver impact.

• Collaborative. We respect one another and partner with integrity.

We value the range of perspectives our people bring, and we work to build an environment where every team member can contribute and grow.

PAY AND BENEFITS

The pay range for this role is listed above. Actual pay depends on factors including experience, skills, and location. Eligible employees in the U.S. receive company-paid medical coverage, flexible spending accounts, voluntary life insurance, 401(k) matching and flexible time off. We are in a brand-new state-of-the art facility in beautiful San Diego with a community gym, dining, and easy access to great places to live and play.

EQUAL OPPORTUNITY

The company is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, medical condition, genetic information, marital status, veteran or military status, or any other characteristic protected by law.