[Hiring] Associate Director Clinical Laboratory Sciences @Lilly

Role Description

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.

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 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.
• 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.

Qualifications

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

Requirements

• 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.

Benefits

• Domestic and international travel required (10%).
• Position location: Indianapolis; remote considered.
• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits.