Associate Director Drug Safety
Clinical-stage life-science and technology company that develops medicines using an AI-driven discovery and development platform.
Funding history
About Iambic Therapeutics
Iambic Therapeutics combines proprietary AI technologies, including Enchant and NeuralPLexer, with automated chemistry and biology experimentation to discover and develop small-molecule medicines. Its current pipeline includes clinical and preclinical oncology candidates.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will oversee internal and outsourced pharmacovigilance activities across oncology development programs. You will manage safety case processing and vendors, coordinate safety data and regulatory deliverables, review safety trends, maintain controlled safety documents, and support compliance, audits, and inspections.
Requirements
- Bachelor's degree in nursing or pharmacy; advanced degree preferred
- At least 10 years of combined relevant experience with a bachelor's degree or 6–8 years with an advanced degree
- Experience in safety science, surveillance, and pharmacovigilance operations
- Knowledge of MedDRA and WHODrug dictionaries
- Proficiency with safety databases
- Ability to train and mentor drug safety personnel
- Knowledge of FDA, EMA, ICH, GCP, and GVP pharmacovigilance requirements
- Oncology Phase I to III experience preferred
Responsibilities
- Oversee internal and external SAE processing activities
- Coordinate reconciliation of safety information across clinical databases and business partners
- Monitor vendor performance and corrective actions
- Support safety database implementation, maintenance, and enhancement
- Contribute to aggregate safety reports and regulatory documents
- Coordinate safety data for reports, submissions, and health-authority requests
- Review individual and aggregate safety data for emerging trends
- Maintain safety management and data exchange documents
- Support CAPAs, change controls, audits, and regulatory inspections
Benefits
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- Uncapped vacation
- Onsite gym
- Onsite dining