Associate Director, Study Operations Manager – Nonclinical Toxicology

Job not on LinkedIn

🔥 8 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $129k - $231k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives • Initiate draft SOWs with multiple CROs for awarded studies in collaboration with toxicology project representatives • Coordinate internal review of draft study protocols and study reports for toxicology and safety pharmacology studies with DMPK, CMC and bioanalytical team members • Coordinate compound shipments with the CMC team • Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, ensuring scientific quality and compliance with global regulatory requirements • Track study deliverables and provide timely progress updates to team members, regulatory leads, and senior management • Maintain an integrated calendar with the Project Management team to forecast portfolio study deliverables and plan resources • Attend project meetings, expedite study-related activities, and provide updates to project teams

🎯 Requirements

• BSc or MSc in toxicology, pharmacology or a related discipline • Minimum 6 years of biotechnology or pharmaceutical industry experience in conducting nonclinical toxicology/safety pharmacology, ADME/DMPK studies with CROs and external development partners • Strong understanding of biological sciences and nonclinical research methodologies • Proven ability to manage multiple simultaneous toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables • Proficiency in scientific data analysis software packages, databases, and data management systems • Excellent oral and written communication, listening, negotiation and interpersonal relationship skills • Experience supporting CNS, neuroscience, sleep-wake, rare disease, or related therapeutic areas • Experience contributing to IND or CTA submissions • Familiarity with FDA, EMA, and ICH regulatory requirements • Experience working in fast-paced, matrixed biotechnology environments • Excellent organizational skills and IT savvy

🏖️ Benefits

• Company bonus depending in part on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups and support networks