Associate Director, Study Operations Manager - Nonclinical Toxicology

BioSpace; Indianapolis (IN); Vor Ort; USD 129.000 - 231.000; Vollzeit

Benefits dieser Stelle

401(k) participation

Health benefits (medical/dental/vision

Well-being programs

Zusammenfassung

Lilly, headquartered in Indianapolis, Indiana, is seeking a senior professional to manage end-to-end data flow between CROs and internal teams for nonclinical toxicology and safety pharmacology programs. The role involves starting draft SOWs with CROs, coordinating study protocols, and ensuring timely, regulatory-compliant study deliverables across DMPK, CMC, and bioanalytical teams.

The candidate will monitor external studies, track progress, and collaborate with regulatory leads and senior

Qualifikationen

• Excellent communication (oral and written)
• Strong understanding of biological sciences and nonclinical research methodologies
• Highly organized with ability to manage multiple studies and data deliverables
• Proficient in scientific data analysis software and data management systems

Aufgaben

• Manage end-to-end data flow between external CROs and internal teams
• Draft SOWs with CROs for awarded studies in collaboration with toxicology representatives
• Coordinate study protocols and reports review with tox/safety pharmacology teams
• Coordinate compound shipments with CMC team
• Monitor nonclinical toxicology and safety pharmacology studies at CROs for quality and regulatory compliance
• Track study deliverables and provide updates to stakeholders to advance drug candidates
• Forecast study deliverables with Project Management for efficient planning
• Attend project meetings and provide updates to teams on request

Kenntnisse

Communication

Biological sciences

Data analysis

Organizational skills

Negotiation & interpersonal skills

Ausbildung

BSc or MSc in toxicology

Related discipline (toxicology/pharmacology)

Jobbeschreibung

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization and Position Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Responsibilities

• 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 to ensure accuracy of study design and to execute SOWs in a timely fashion.
• Coordinate with CRO study director to initiate the internal reviewing process of draft study protocols and study reports for tox/safety pharm studies with DMPK, CMC and bioanalytical team members
• Coordinate compound shipments with 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 relevant team members, regulatory leads, and senior management in order to advance drug candidates through research and development
• Maintain an integrated calendar by working with Project Management team to forecast study deliverables across entire portfolio for efficient planning of resources
• Attend project meetings to stay informed and expedite study-related activities as needed, and provide updates to project teams upon request

Basic 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
• Highly organized, with 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
• Must have excellent communication (oral and written), listening, negotiation and interpersonal relationship skills

Additional Preferences

• 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
• Embrace ambiguity and push for new practices and technologies
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $129,000 - $231,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits and Compensation

In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

• eligible to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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