Senior Advisor, Study Operations Manager – Nonclinical Toxicology

🕒 Outubro 27

🍂 Massachusetts – Remoto

🍂 Massachusetts – Remote

💵 $144.000 - $231.000 / ano

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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Eli Lilly and Company

SiteLinkedInTodas as Vagas

10.000+ funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

💰 $6.500.000 Post-IPO Debt - Eli Lilly em 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company é uma empresa farmacêutica multinacional que pesquisa, desenvolve, fabrica e comercializa medicamentos de prescrição em várias áreas terapêuticas, incluindo diabetes, oncologia, imunologia, neurociência e dor. Com sede em Indianápolis, Indiana, Lilly é conhecida por sua extensa P&D, desenvolvimento clínico e comercialização global de medicamentos biológicos e de pequenas moléculas. A empresa foca na descoberta de medicamentos, ensaios clínicos, aprovações regulatórias e fabricação e distribuição farmacêutica em larga escala.

Descrição

• Manage and oversee day-to-day operations for toxicology and safety pharmacology studies conducted at selected CROs • Manage end-to-end data flow between external CROs and internal teams • 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 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, for scientific quality and regulatory compliance • Track study deliverables and provide progress updates to team members, regulatory leads and senior management • Maintain an integrated calendar to forecast study deliverables and plan portfolio resources • Attend project meetings, expedite study-related activities, and provide updates to project teams

🎯 Requisitos

• 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 • 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 • Ability to embrace ambiguity and adopt new practices and technologies • Adaptive problem-solving ability

🏖️ Benefícios

• 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 • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups open to all employees

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