- 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 CLDS 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
- 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
- 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
- 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 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.
- Advanced degree (e.g. MSc, PhD) in a scientific or health care field
- 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
- Domestic and international travel required (10%), required
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Associate Director - Cork, Ireland - Lilly
Description
We're looking for people who are determined to make life better for people around the world.
At Eli Lilly Cork, 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 41,000 employees around the world 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 give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Purpose:
The 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: 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.
Portfolio Strategy, Planning and Delivery
Project Management
People Development
Minimum Qualification Requirements:
Other Information/Additional Preferences:
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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