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Position Summary:

The Associate Director, Diagnostic Development will serve as the investigational in vitro diagnostic (diagnostic) trial-level expert for global clinical studies where approved diagnostics are needed to support the therapeutic program. The ideal candidate will have experience in diagnostics, clinical trial management and/or monitoring.

Responsibilities:Lead global, cross-functional discussions with physicians, scientists, and clinical operations to solve sophisticated, outstanding, and specialized diagnostic implementation issuesManage the relationship and serve as the focal point of communication with clinical research teams at the trial level for diagnostic trial deliverablesProvide clinical operations expertise and input during protocol development and feasibility assessment. Recognized as a resource across teams for diagnostic operational knowledge of clinical planning and deliveryOwn the delivery of appropriate language for global study drug protocols when a diagnostic is included to ensure appropriate number and type of samples are collected and the diagnostic is appropriately describedReview diagnostic testing protocols, statistical analysis plans, Clinical Study Reports, and other diagnostic project documentation.Prepare and ensure documents associated with the implementation of global clinical trials (such as informed consents, case report forms, sample flow, lab manuals and lab requisition forms) contain appropriate information for diagnostic development. Proactively ensure complete, timely documentation for clinical trial planning and executionLead work with internal clinical laboratory operations to help select appropriate clinical lab testing sitesLead efforts with data operations to ensure external diagnostic partners receive data transfers of test results per their specifications and the data collected will meet the needs of regulatory submissionsServe as primary reviewer of the diagnostic portions of the lab manuals to guide the clinical investigational sites (sites enrolling patients) to ensure information on pre-analytical processes is included and is appropriate for the diagnostic. Develop trial-specific training for the diagnostic sample requirements and testingManage collection and provision of global investigator site and IRB information for regulatory submissions (IDE and annual reports).Coordinate and document reviews of key documents for diagnostic development such as intended use statements, user needs, milestone reports, regulatory documents developed by external diagnostic partnersAssist with tracking patient enrollment and collaborate with operations team to drive mitigation and contingency actions to address enrollment issues, where applicableMaintain deep clinical development process expertise to ensure implementation of diagnostic strategy is current with all global policies/procedures and best practicesLead/participate in the revision and/or development of new global SOPs to address diagnostic development in collaboration with quality organizations as well as procedures for departmental useBasic Qualifications:Bachelor of Science (Scientific, Engineering or Medical Health-related field) with 8+ years experience in lab or pharma/biotech industry or,Masters’ degree in (biology, molecular biology or genetics preferred) and five years of experience in lab or pharma/biotech industry.Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment positionAdditional Skills and Preferences:Molecular pathology laboratory experience a plusUnderstand commercial diagnostic partners’ design control processContribute to internal governing bodies’ reviews and approvals (scope, time, budget, resources, etc.)Understand the global drug development processStrong communication skills, both written and oralExcellent interpersonal skills and experience working and negotiating with external diagnostic partnersExperience with clinical operationsExperience with performing detailed data reviewsExperience with genetic testing or genetic data, including next generation sequencing and polymerase chain reactionStrong self-management skillsExcellent problem-solving abilitiesMulti-tasking capability with the ability to prioritize and meet critical deadlines in all projectsProven track record of well-executed delivery to deadlines

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

$111,000 - $162,800

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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