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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

At JP Morgan 2024, Dave Ricks announced Lilly Catalyze360, our external innovation organization dedicated to biotech collaboration which is comprised of three pillars: Lilly Ventures, providing capital direct to biotechs and via a fund-of-funds investment strategy; Lilly Gateway Labs, a best-in-class network of biotech incubators; and ExploR&D.

Within ExploR&D our mission is unleash Lilly’s world-leading capabilities and know-how to accelerate the science of our biotech collaborators to value inflection, and to patients. Through a unique model that mixes dedicated headcount and flexible use of functional and therapeutic area expertise, we will provide the knowledge and services to enable our collaborator’s programs. Through our work we ensure Lilly is networked with the brightest scientific minds around the world to continue to make Lilly smarter, create value for Lilly and the entire scientific ecosystem, and position Lilly as a partner of choice for biotechs to fuel our industry-leading pipeline with best external innovation. With the pace of technological disruption accelerating, ExploR&D also affords Lilly an agile way to pilot and deploy new technologies and vendor solutions that can increase the speed and efficiency in the way drugs are discovered and developed, both for our biotech collaborators, and by providing de-risked opportunities to evolve how Lilly and LRL operates.

The purpose of the job is to ensure ExploR&D has adequate Good Clinical Practices (GCP) systems in place that are properly executed. Reponsibilities include assurance of adequate, phase appropriate, fit for purpose systems for ExploR&D to conduct GCP-regulated work, in accordance with the ExploR&D Quality System as well as applicable regulations and international guidelines. Responsibilities also include performiong or managing GCP audits and assessments of Clinical Third Party Organizations as needed.

This role will contribute to ExploR&D maintaining a strong Quality Culture, that enables robust business partnerships with external companies developing molecules in early phase clinical trials.

Responsabilities:

GCP Quality: Role-based Training Plan (ExploR&D GCP Quality)

+ Closely collaborate with ExploR&D Clinical Operations teams to anticipate, track, and schedule assessments of clinical research organization (CROs), clinical research units (CRUs), Clinical Laboratories, and other potential third parties.

+ Conduct GCP audits and assessments of clinical third party vendors, including CRUs and Investigator Sites, resolve observations with input from ExploR&D Clinical Operations and ExploR&D Quality Management. Make recommendations regarding potential risks, impact of the observations, and vendor suitability for use in clinical trials.

+ Participate in the management/development of GCP components within the ExploR&D Quality organization. Such work may include authoring and/or the review/approval of ExploR&D Quality Sysyem Documents, deviations, and associated personnel training.

+ Monitor changes to GCP regulations and other developments in the industry and advise ExploR&D Management as to their potential impacts on the overarching ExploR&D Quality strategy.

+ Actively contribute and provide quality consultation to ExploR&D Clinical and cross-functional teams. Participate in program team meetings and closely partner with Clinical Operations to advise on and provide guidance regarding GCP matters in real time.

+ Provide consultation to Lilly and External Sponsors.

+ Support the GCP Audit Plan for ExploR&D.

+ Ensure GCP-regulated documents are retained and readily accessible as required by regulations and to support audits.

+ Ensure access to ExploR&D group records is restricted to personnel on a need-to-know basis and under conditions that ensure study integrity and confidentiality.

+ Use and contribute to development of ExploR&D’s IT systems, including Document Management and Learning Management Systems.

Basic Qualifications:

+ At a minimum, a Bachelors degree in a science-related field from an accredited college or university.

+ **5+ years auditing GCP third parties** , including CROs, CRUs, Clinical Laboratories, Bioanalytical Labs, and Investigator sites across a wide range of therapeutic areas, in the US and outside the US.

Additional Skills and Preferences:

+ Demonstrated ability to think independently.

+ Demonstrated problem-solving capabilities.

+ Excellent verbal and written communication skills.

+ Ability to work in areas of ambiguity, sometimes with limited data, to provide reasonable, sound and timely decisions regarding GCP Quality.

+ A thorough understanding of early phase clinical research (Ph 1-Ph 2a)

+ Work experience with GMP and GLP regulations over and above the GCP requirement is desirable, but not required for this position.

+ Demonstrated ability to influence both internal and external partners to maintain a "Quality as a Culture" way of doing business.

+ Leverage expertise to actively coach individuals across functions.

+ Strong negotiation skills.

+ Ability to provide sound, compliant Quality solutions, in a clinical phase-appropriate manner with business objectives and timelines in mind.

+ Drive continuous process improvement initiatives and contribute to Quality Plan activities

+ Knowledge of GCLPs

+ Able to simplify processes, build capabilities, and implement value-added streamlined solutions.

Additional Information:

+ Travel percentage: up to 10% US/OUS (0-10%)

+ Location: Preference for Indianapolis, IN but open to US remote for qualified candidates

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$121,500 - $198,000

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