Work with business and therapeutic teams to develop clinical lab, diagnostic, and biomarker strategies for trials and compounds
Collaborate on trial design and shape protocol design for both CLS operations and patient/site requirements
Oversee project management including budgets, timelines, risks, and vendor performance
Execute clinical and biomarker sampling plans for clinical trials by working with Clinical Laboratory Sciences Associates (CLA’s)
Maintain accurate inventory of research and clinical/preclinical samples across drug programs and third-party labs
Participate in budget planning activities and provide precise, integrated cost/time estimates
Offer expert consultation and track/resolve discrepancies with study team, sites, or CRO vendors
Promote knowledge sharing, improve processes, and implement new efficient processes
Identify functional capability gaps and proactively address them to accelerate portfolio delivery
Provide oversight of central labs, CROs and data deliverables to support eTMF and DBLs
Participate in regulatory audits and submission-related activities
Serve as a therapeutic and clinical laboratory expert to the CLA’s and provide coaching that fosters inclusion and continual improvement
Requirements
Bachelor’s degree with at least three years of experience in clinical drug development, preferably in oncology, with a focus on laboratory sciences and diagnostics and a solid scientific background
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)
Advanced degree (e.g. MSc, PhD) in a scientific or health care field strongly preferred
Companion Dx development experience and sample management
Experienced in clinical diagnostic and laboratory needs in oncology in a regulated setting
Demonstrated ability to set and implement strategies and plans to improve complex oncology drug development processes and capabilities
Demonstrated analytical, technological, and project management expertise
Proven ability to influence cross functionally without direct authority
Proven ability to lead development of creative clinical laboratory solutions to address oncology clinical development challenges
Proven ability to develop diverse organizational talent with next level potential
Domestic and international travel required (10%)
Benefits
Company bonus (depending, in part, on company and individual performance)
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
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