Associate Director, Clinical Laboratory Sciences

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 Associate 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 AD 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.

Primary Responsibilities :

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 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 United States. 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

Experience in the Neuroscience therapeutic space

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

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

Strong communication skills.

Domestic and international travel required (10%), required