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
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job
responsibilities and any related duties that may be required for the position.
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). 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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