Senior Advisor, Study Operations Manager – Nonclinical Toxicology

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $144k - $231k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

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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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 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 • Execute SOWs in a timely fashion • Coordinate with CRO study directors to initiate internal review of draft study protocols and study reports for toxicology and safety pharmacology studies • Coordinate compound shipments with the CMC team • Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, to ensure scientific quality and compliance with global regulatory requirements • Track study deliverables and provide timely updates on study progress to team members, regulatory leads, and senior management • Maintain an integrated calendar with the Project Management team to forecast study deliverables across the portfolio and plan resources efficiently • Attend project meetings and expedite study-related activities as needed • Provide updates to project teams upon request

🎯 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 • Proficient in scientific data analysis software packages, databases, and data management systems, with the ability to quickly learn and adapt to new software tools • Excellent communication (oral and written), 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 • IT savvy • Intrinsically curious and deeply passionate about the work we do • Ability to embrace ambiguity and push for new practices and technologies • Adaptive problem-solving ability

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical benefits • Dental benefits • Vision benefits • Prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Employee assistance program • Fitness benefits • Employee clubs and activities

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