Iambic TherapeuticsAssociate Director, Drug Safety
Iambic Therapeutics is hiring an Associate Director, Drug Safety for a remote role open to applicants in United States. It pays $164k-$205k a year and Level rates it ; you can apply on Iambic Therapeutics.
Level's read on this job
- Level rates this role Little AI ●○○○: aI is not part of the work.
- The posting lists this role as remote.
- Tools and skills the posting cites include Meddra, Whodrug and pharmacovigilance.
- Level classifies it as a senior role.
- Level lists 29 other open roles at Iambic Therapeutics.
AI in this role
Oversees outsourced pharmacovigilance activities, safety databases, and regulatory compliance for oncology therapies.ing
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.
ABOUT IAMBIC THERAPEUTICS
Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.
MISSION & CORE VALUES
Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
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.
How we rate this
Associate Director, Drug Safety at Iambic Therapeutics rates 0 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.
Little AI. AI is not part of the work.
- ●●●● Builds AI80 to 100
- ●●●○ Works on AI60 to 79
- ●●○○ Uses AI40 to 59
- ●○○○ Little AI0 to 39
Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.
Prepare for this job
Built from this posting and from similar jobs on Level.
Skills and AI tools this role asks for
Questions you could be asked
- Tell me about a project where pharmacovigilance was part of your work. What did you do?
- Tell me about a project where drug safety was part of your work. What did you do?
- Tell me about a project where regulatory compliance was part of your work. What did you do?
- Tell me about a project where clinical operations was part of your work. What did you do?
- Walk me through how you've used Meddra in your day-to-day work.
Adapt your resume
- List these exact terms on your resume: Pharmacovigilance, Drug Safety, Regulatory Compliance, Clinical Operations, and Meddra. An applicant tracking system matches the wording, not the idea.
- Attach one line of real, concrete experience to at least one of them. A tool named with nothing behind it rarely survives a human read.
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