Job Description

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 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 people around the world.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.


At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.


The purpose of the Clinical Development Trial Lead (CDTL) role related to the exploratory and biopharmaceutics clinical development is to lead study teams of internal and external partners in the planning and execution of studies within the clinical plan. The CDTL achieves this while ensuring quality on-time and on-budget fulfillment of study deliverables. The CDTL may also support non-study project assignments to transform and improve the business. The Associate will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities.

Responsibilities:

Project Management and Regional Operational Knowledge

Scope - Understand the scope of work required to complete the post-marketing studies/trials (henceforth referred as studies/trials) successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the study/trial. Timeline - Develop and track the enrollment plan by gaining alignment and integrating inputs across functions and geographies. Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, study/trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan. Budget - Understand the cross-functional, trial-level budget components. Monitor the overall budget. Routinely network with appropriate business partners, on trial-level budget status and changes. Partner with other organizations to coordinate and actively participate in affiliate, site, and investigator training as applicable Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution, and closure, empowering them to meet the study/trial deliverables, including issue management, contingency planning and issue resolution. Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET). Manage relationships and serve as a single point of contact and central owner for trial communication Apply problem-solving skills to daily issues with cross-functional study team (including with vendors, affiliates/regions, global team members and other business partners). Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc. Manage TPO qualification process, selection, and oversight.

Clinical Trial Process Leadership and Expertise

Demonstrate understanding of drug development process. Acknowledge inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall study/trial. Look for opportunities to expand and deepen study/trial process expertise. Be knowledgeable of the global and regional operating model; coordinate and facilitate geographic and functional input to provide to the study teams. Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, and finalized Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown, assess situations and propose proactive approaches that reduce and/or mitigate risks that impact ability to deliver the study/trial. Demonstrate ability to lead and influence in the midst of ambiguity and coach peers, cross-functional team members and TPOs on aspects of study/trial process and regional specificities. Report, manage and interpret information for the studie(s)/trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure. Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of studies/trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.

Scientific Expertise

Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates. Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation. Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.

Basic Requirements:

Bachelors or University degree (scientific or health-related field preferred) and 10 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree

Additional Preferences:

Strong leadership and networking skills. Strong communication skills. Demonstrated problem-solving abilities Strong self-management, organizational and interpersonal skills. Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities. Previous experience working in cross-functional teams or projects Ability to travel (up to 10% expected - varies dependent on responsibilities) Prior clinical trial site-level or affiliate experience Proficiency in use of project management tools and t

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 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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