Senior Advisor, Study Operations Manager – Nonclinical Toxicology

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $144.000 - $231.000 / ano

⏰ Tempo Integral

🟠 Sênior

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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

A Eli Lilly and Company é uma empresa farmacêutica global que pesquisa, desenvolve, fabrica e distribui medicamentos prescritos, além de fornecer serviços de apoio ao paciente. A empresa se concentra em medicamentos que mudam vidas em áreas como diabetes, câncer, doença de Alzheimer, distúrbios autoimunes, dermatologia, enxaqueca, obesidade e apneia do sono. Ela realiza ensaios clínicos, oferece serviços de farmácia LillyDirect e enfatiza a qualidade de fabricação, segurança de medicamentos e pesquisas em medicamentos genéticos. A Eli Lilly também oferece recursos para pacientes, educação sobre condições de saúde e programas de acesso para ajudar as pessoas a encontrar cuidados e participar de ensaios.

Descrição

• 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

🎯 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, 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

🏖️ Benefícios

• 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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