Associate Director, Drug Safety

🕒 September 16

🇺🇸 United States – Remote

💵 $164k - $205k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 12%

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Oversee outsourced pharmacovigilance activities and contribute to regulatory and safety deliverables • Work collaboratively with Quality, Clinical Operations, and Clinical Development to establish and execute safety processes • Provide day-to-day oversight of internally and externally performed SAE processing • 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, Safety Data Exchange Agreements, and other inspection-readiness documents • Support CAPAs, change controls, audits, and regulatory inspections • Perform responsibilities across all phases of development for oral small-molecule oncology therapies • Report to the Head of Safety

🎯 Requirements

• Bachelor's degree in nursing or pharmacy required • 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 • 6–8 years of relevant experience 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 and 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 • Must be currently authorized to work in the United States • Must disclose whether visa sponsorship is currently or prospectively required

🏖️ Benefits

• Company-paid healthcare • Flexible spending accounts • Voluntary life insurance • 401(k) matching • Uncapped vacation • Onsite gym • Dining at the facility • Flexible remote work arrangement / option to work from San Diego headquarters

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