Associate Director - Clinical Laboratory Sciences

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.

The 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 indepth knowledge and expertise in clinical laboratory practices and processes.

Portfolio Strategy, Planning and Delivery

• Partner early on asset development with Research (including ADME/PK, Toxicology, Patient Tailoring and Laboratory and Eperimental 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 CLDS 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

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

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 and 3 years of experience in clinical drug development with expertise in lab sciences and diagnostics
• 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
• Qualified candidates must be legally authorized to be employed in the country. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B, or TN status) for this employment position

Other Information/Additional Preferences:

• Advanced degree (e.g. MSc, PhD) in a scientific or health care field
• 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
• Domestic and international travel required (10%), required

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

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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