| Job Description | Job Description
For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a Best in Class Pharmaceutical company, please review the following opportunity:
Diagnostics Research & Development Associate Consultant
Lilly Diagnostics’ (Dx) mission is to deliver diagnostic solutions that enhance disease understanding and guide optimal patient treatment. Lilly Diagnostics will partner with external companies to develop, validate, and commercialize diagnostic assays in support of Lilly’s drug portfolio. The Dx Research & Development associate consultant works closely with internal Dx functions, Clinical Diagnostic Laboratory (CDL) and Commercialization, to implement Dx strategy on individual drugs (or related compounds) set forth jointly by the drug and Dx teams. In addition, the Dx R&D associate consultant will work closely with Lilly drug development functions and external diagnostics development partners in ensuring the timely deliverables of commercial Dx assays, platforms and information for seamless integration with drug development.
Key Objectives/ Deliverables:
Scientific & Technological Expertise
• Coordinate and document reviews of product requirements document as well as other key documents for diagnostic development such as intended use statements, user needs, and study reports
• Write sections of monitoring plan relevant to diagnostics development to ensure compliance with appropriate regulations (Good Clinical Practice) and review monitoring reports
• Set up and maintain collaboration sites for review of documents and for storage of meeting minutes and other project related documents
• Participate in the development of study drug protocols when a commercial Dx is included to ensure appropriate type and number of samples are collected
• Review the lab manual prepared by the central lab to ensure language on pre-analytical processes is included and is appropriate for commercial diagnostic (for example, sample collection, storage, transport, storage, and use and disposal language, etc.)
• Work with Clinical Diagnostics Services to ensure sample management needs of commercial diagnostics (for example, sample collection, storage, tracking and required documentation) and to confirm other needs of diagnostic development such as number and
identification of performing labs are met
• Assist in building linkage between Dx commercial partners design control process
with Lilly drug development process and ensure the seamless integration where the linkages are critical for the success of Dx and drug, for example, building timeline, identifying and developing risk plans, etc.
• Quality check (both content and format) for medical contributions to regulatory submission (for example, pre-IDE briefing document, PMA)
• Maintain Regulatory binder (record retention, review. etc) for PMA submission (for example, financial disclosure, etc.)
• Assists in the preparation for meetings with Regulatory Agencies
Process Expertise
• Assist and/or develop new standard operating procedures (SOPs) and RACIs for review of documents such as milestone gate review reports, regulatory submission documents, etc.
• Maintain process expertise to ensure implementation of diagnostic strategy is current with Lilly policies/procedures and best practices
• Act as expert in ensuring regulatory documents are inspection ready (for example, data integrity, secure data transfer, data and report format, data modules/packages, etc.)
• Contribute to internal governing bodies’ reviews and approvals (scope, time, budget, resources, etc.)
• Identify opportunities for process improvement and lead or participate in cross-functional process improvement activities related to Dx development
• Work with external sourcing and alliance management to coordinate and plan governance meetings with external partners
• Set up shopping carts and purchase orders through procurement and track the expense if needed or work with external sourcing to enter eBuy requests
Work with external collaborators
• Understand commercial Dx partners’ design control process. Promote collaborative relationships with external partners.
• Lead transfer of assays and information to external partners and vice versa
• Collaborate with Medical Quality organization to define and monitor partners’ quality standards
• Collaborate with External Sourcing to develop metrics to track performance
Communication/Shared Learning
• Maintain open lines of communication with management, customers, and partners to relay critical issues
• Facilitate and share institutional learning across LRL and act as a subject matter expert (SME) for commercial Diagnostics assays and technological advancement in the therapeutic areas of interest. Stay up-to-date with current literature on the Dx assays/platforms, competitors information and industry trend.
Minimum Requirements:
• Bachelor of Science or equivalent (Scientific, Engineering or Health-related field)
• 3 years of experience and understanding of the drug development process
• Qualified candidate 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 position
Additional Skills/ Preferences:
• Strong communication skills, both written and oral
• Excellent interpersonal skills and experience working and negotiating with external partners
• Ability to navigate gray space and engage others appropriately when path forward isn’t fully defined
• Strong self management skills and excellent problem-solving abilities
• Multi-tasking capability with the ability to prioritize and meet critical deadlines in all projects
• Proven track record of well-executed delivery to deadlines
• Significant prior experience in molecular, immunohistochemistry and/or immunoassay Diagnostics development
• Knowledge of and experience with application of Design Controls in Diagnostics development
• Understanding of Diagnostic CDRH submission requirements for 510(k)s and PMAs
Other Considerations:
• Occasional travel in US and/or OUS may be required |
| | Company | | Eli Lilly & Co | Job Code | | State or Province | | Indiana | | |
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