Associate Director Clinical Laboratory Sciences

Eli Lilly and Company; United States; Hybrid; USD 117,000 - 189,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical coverage

Dental coverage

Flexible benefits

Life insurance

Job summary

Lilly is seeking a TA Associate Director/Director, Clinical Laboratory Sciences to shape clinical laboratory and diagnostic strategies across molecules. You will engage with R&D teams, design plans, manage budgets and timelines, and supervise vendor performance to deliver reliable CLS outcomes.

We seek deep expertise in clinical laboratory practices, cross-functional leadership, and the ability to influence protocol design.

Qualifications

• Bachelor’s degree in a scientific field.
• 3 years of experience in clinical drug development with expertise in lab sciences and diagnostics.
• Advanced degree (e.g. MSc, PhD) in a scientific or health care field preferred.

Responsibilities

• Develop and document clinical laboratory and diagnostic strategies at the molecule level.
• Manage budgets, timelines, risk, and vendor performance for trials.
• Provide coaching and leadership to CLS Associates to foster inclusion and innovation.

Skills

Clinical laboratory practices

Budget management

Cross-functional leadership

Education

Bachelor’s degree in science

Advanced degree (MSc/PhD)

Tools

Clinical lab tools

Job description

Organization Overview

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Primary Responsibilities

The Therapeutic Area (TA) Associate Director/Director, Clinical Laboratory Sciences will have early engagement with the appropriate business and therapeutic partners on development of the clinical laboratory, diagnostic and biomarker strategies at the compound level. The TA Associate Director/Director engages at a trial level with the therapeutic area, clinical design and other appropriate partners to develop a design plan that can be executed by the study team for the trial. Project management at a molecule level including budget, timelines, risk evaluation and vendor performance monitoring are part of the responsibilities of the role. The role requires in-depth knowledge and expertise in clinical laboratory practices and processes.

1. Portfolio Strategy, Planning and Delivery

• Partner early on asset development with Research (including ADME/PK, Toxicology, Patient Tailoring and Laboratory and Experimental Medicine) to develop and document the clinical laboratory and diagnostic strategies and plans at the molecule level.
• Influence protocol design to meet the needs CLS operations as well as the patient/site
• Optimize costs associated with molecule clinical laboratory plans and deliver integrated and accurate cost/time estimates
• Provide expertise and consultation related to clinical laboratory planning
• Facilitate and share learnings across the collective CLS organization as well as feedback loops to clinical design
• Work to improve existing processes and to implement new processes
• Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays
• Proactively drive the use of clinical laboratory processes and tools to accelerate portfolio delivery and deliver to plan
• Provide oversight of vendor planning and deliverables and partner with the technical consultants as needed to reach issue resolution; articulate portfolio demand with vendor
• Oversight of quality delivery of eTMF

2. Project Management

• Manage key partnerships and interactions/integration across the cross functional clinical team
• Proactively identify critical decision points that must be made and ensure that the key technical/scientific experts are involved
• Bring greater value to the portfolio by anticipating issues and identifying opportunities for which clinical laboratory solutions can be applied
• Drive communications to prospectively manage upcoming cross-functional activities, key milestones and decisions as well as proactively partner to optimize the timeline
• Articulate the value of clinical laboratory solutions in terms of reliability, time, cost, quality and scalability
• Drive clinical laboratory data completeness and accuracy within business systems
• Monitoring of budgets for any potential cost saving options

3. People Development

• Serve as a therapeutic and clinical laboratory expert to the Clinical Laboratory Sciences Associates
• Model the Lilly leadership behaviors
• Provide coaching within the organization that fosters inclusion and innovation, continual improvement, and an external awareness and understanding

Minimum Qualification Requirements

• Bachelor’s degree
• 3 years of experience in clinical drug development with expertise in lab sciences and diagnostics

Additional Preferences

• Advanced degree (e.g. MSc, PhD) in a scientific or health care field
• Demonstrated ability to understand the clinical diagnostic and laboratory needs of a particular therapeutic area or 2 years
• of Clinical Laboratory Management in a regulated environment
• Demonstrated knowledge of drug development processes
• Demonstrated ability to set and implement strategies and plans to improve complex drug development processes and capabilities.
• Demonstrated ability to effectively partner/influence cross functionally to deliver results
• Familiarity with clinical lab tools and technologies
• Strong communication skills
• Proven ability to influence cross functionally without direct authority
• Proven ability to lead development of creative clinical laboratory solutions to address clinical development challenges
• Proven ability to develop diverse organizational talent with next level potential

Additional Information

• Domestic and international travel required (10%), required
• Position location: Indianapolis; remote considered

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 $117,000 - $189,200

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

• 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
• 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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