Eli Lilly and Company
Associate Director - Clinical Laboratory Sciences
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Overview
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 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 look for people who are determined to make life better for others. Position
The TA Associate Director/Director, Clinical Laboratory Sciences will engage early with the appropriate business and therapeutic partners on the development of the clinical laboratory, diagnostic and biomarker strategies at the molecule level and at trial level. The role includes project management (budget, timelines, risk evaluation and vendor performance monitoring) and requires in-depth knowledge and expertise in clinical laboratory practices and processes. Responsibilities
Portfolio Strategy, Planning and Delivery: Partner early 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 of CLS operations as well as the patient/site. Optimize costs associated with molecule clinical laboratory plans and provide integrated and accurate cost/time estimates. Provide expertise and consultation related to clinical laboratory planning. Facilitate and share learnings across the CLDS organization and provide feedback loops to clinical design. Improve existing processes and implement new ones. Identify key functional capability gaps early to ensure robust processes and manage expectations to avoid downstream delays. Proactively drive the use of clinical laboratory processes and tools to accelerate portfolio delivery and meet the plan. Provide oversight of vendor planning and deliverables; partner with technical consultants as needed to resolve issues and articulate portfolio demand with vendors. Oversee quality delivery of eTMF. Project Management: Manage key partnerships and interactions across the cross-functional clinical team. Identify critical decision points and ensure involvement of key technical/scientific experts. Anticipate issues and identify opportunities for applying clinical laboratory solutions to add value to the portfolio. Drive communications to manage cross-functional activities, milestones and decisions; proactively partner to optimize timelines. 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. Monitor budgets for potential cost-saving options. People Development: Serve as a therapeutic and clinical laboratory expert to the Clinical Laboratory Sciences Associates. Model Lilly leadership behaviors. Provide coaching that fosters inclusion, innovation, continual improvement, and 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 therapeutic area, or 2 years of Clinical Laboratory Management in a regulated environment. Qualified candidates must be legally authorized to work in the country. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B, or TN status) for this position. Other Information / Additional Preferences
Advanced degree (e.g., MSc, PhD) in a scientific or health care field. Knowledge of drug development processes. Ability to set and implement strategies to improve complex drug development processes and capabilities. Ability to partner/influence cross-functionally to deliver results. Familiarity with clinical lab tools and technologies. Strong communication skills. Ability to influence cross-functionally without direct authority. Ability to lead development of creative clinical laboratory solutions to address challenges in clinical development. Ability to develop diverse organizational talent with next-level potential. Domestic and international travel required (10%). Accommodation and Equal Opportunity
Lilly is dedicated to helping individuals with disabilities participate in the workforce and provides accommodations for applicants. If you require accommodation to submit a resume, please complete the accommodation request form at the Lilly Careers site. 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 members and are open to all employees. Learn more about all of our groups. Compensation and Benefits
Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position ranges from $115,500 to $169,400. Full-time employees are eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program, including eligibility for a 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; leave benefits; and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
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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 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 look for people who are determined to make life better for others. Position
The TA Associate Director/Director, Clinical Laboratory Sciences will engage early with the appropriate business and therapeutic partners on the development of the clinical laboratory, diagnostic and biomarker strategies at the molecule level and at trial level. The role includes project management (budget, timelines, risk evaluation and vendor performance monitoring) and requires in-depth knowledge and expertise in clinical laboratory practices and processes. Responsibilities
Portfolio Strategy, Planning and Delivery: Partner early 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 of CLS operations as well as the patient/site. Optimize costs associated with molecule clinical laboratory plans and provide integrated and accurate cost/time estimates. Provide expertise and consultation related to clinical laboratory planning. Facilitate and share learnings across the CLDS organization and provide feedback loops to clinical design. Improve existing processes and implement new ones. Identify key functional capability gaps early to ensure robust processes and manage expectations to avoid downstream delays. Proactively drive the use of clinical laboratory processes and tools to accelerate portfolio delivery and meet the plan. Provide oversight of vendor planning and deliverables; partner with technical consultants as needed to resolve issues and articulate portfolio demand with vendors. Oversee quality delivery of eTMF. Project Management: Manage key partnerships and interactions across the cross-functional clinical team. Identify critical decision points and ensure involvement of key technical/scientific experts. Anticipate issues and identify opportunities for applying clinical laboratory solutions to add value to the portfolio. Drive communications to manage cross-functional activities, milestones and decisions; proactively partner to optimize timelines. 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. Monitor budgets for potential cost-saving options. People Development: Serve as a therapeutic and clinical laboratory expert to the Clinical Laboratory Sciences Associates. Model Lilly leadership behaviors. Provide coaching that fosters inclusion, innovation, continual improvement, and 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 therapeutic area, or 2 years of Clinical Laboratory Management in a regulated environment. Qualified candidates must be legally authorized to work in the country. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B, or TN status) for this position. Other Information / Additional Preferences
Advanced degree (e.g., MSc, PhD) in a scientific or health care field. Knowledge of drug development processes. Ability to set and implement strategies to improve complex drug development processes and capabilities. Ability to partner/influence cross-functionally to deliver results. Familiarity with clinical lab tools and technologies. Strong communication skills. Ability to influence cross-functionally without direct authority. Ability to lead development of creative clinical laboratory solutions to address challenges in clinical development. Ability to develop diverse organizational talent with next-level potential. Domestic and international travel required (10%). Accommodation and Equal Opportunity
Lilly is dedicated to helping individuals with disabilities participate in the workforce and provides accommodations for applicants. If you require accommodation to submit a resume, please complete the accommodation request form at the Lilly Careers site. 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 members and are open to all employees. Learn more about all of our groups. Compensation and Benefits
Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position ranges from $115,500 to $169,400. Full-time employees are eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefits program, including eligibility for a 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; leave benefits; and well-being programs. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.
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