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\xe2\x80\x99re looking for people who are determined to make life better for people around the world.The Trial Capabilities Associate Director leads clinical trial capabilities in support of clinical development for site activation, maintenance and close out utilizing deep technical expertise and understanding of cross functional dependencies to drive and implement process improvements to enhance regulatory submission strategy, site budget and contract negotiation, clinical finance and payment and trial metrics across all therapeutic areas to enable end to end Trial Capabilities deliverables.Clinical Trial Leadership

• Lead and coordinate the execution of clinical trials across country/region for high priority and complex trials representing the geographical complexity.
• Leverage deep expertise in regional trial execution to represent Trial Capabilities in global cross functional clinical trial forums.
• Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across country/region/globe.
• Influence study design and execution based on knowledge of regulations and applying the learnings from regulatory/ERB feedback gained from other programs. Recognized as a leader representing Trial Capabilities for the country/region providing guidance to study teams on regulatory acceptance of specific protocol elements and how to respond to regulatory queries.
• Lead and provide input into the design and implementation of regional/global functional projects value-added solutions that will drive automation to enhance Trial Capabilities effectiveness and productivity and enable acceleration of enrollment readiness.
• Leverage scientific and disease expertise within therapeutics areas and utilize strategic knowledge of Lilly\xe2\x80\x99s portfolio and priorities to lead country/regional prioritization and anticipate future needs for Trial Capabilities.
• Recognized as an expert in local/global regulations, laws, and guidance (e.g., ICH), and assess the impact on local and global processes ensuring internal processes and procedures reflect and comply with country requirements.
• Lead and consult on internal audits and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives.

Business Management and Externa Influence

• Drive discussions with regulatory bodies / ERBs providing rational for specific protocol elements and ICF language.
• Engage with regulatory bodies and ERB to influence and challenge internal and external factors shaping clinical trial execution e.g., Decentralized Trial model and trial mitigations impacted by unforeseen circumstances.
• Lead and share technical and operational expertise across the Global Trial
• Lead Trial Capabilities team to effectively manage study start-up. Recognized as an expert in local/global regulations, laws, and guidance (e.g., ICH), and assess the impact on local and global processes ensuring internal processes and procedures reflect and comply with country requirements.
• Proactively identify process improvement opportunities and collaborate with the CDDA functions to re-design more effective and efficient processes including building clear accountabilities and responsibilities for vendors to ensure optimized delivery at country/region and global level.
• Identify and develop robust mechanisms to retain a scientific, technical, and operationally capable Trial Capabilities workforce skilled and knowledgeable in clinical development.
• Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.
• Understand and comply with procurements, legal, data privacy and financial requirements and procedures.

Organizational Leadership

• Identify and ensure shared learning across the clinical organization and with other functional groups within CDDA.
• Build capabilities in the function through the development and improvement of processes, tools and training and partnering with CDDA functions to leverage technology to increase efficiency of clinical trial capabilities and resources.
• Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.
• Manage staff compliance to local regulations and guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).

People Management and Development

• Recruit, develop, and retain an operationally capable workforce skilled and knowledgeable in clinical development.
• Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
• Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.

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 ( ) 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.#WeAreLilly

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