Clinical Development Trial Lead

Associate - Clinical Development Trial Lead

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.

Purpose : The Associate - Clinical Development Trial Lead (CDTL) leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial objectives.

Trial Leadership, and Regional Operational Knowledge

Use processes and tools to develop, implement, and deliver local, regional and / or global clinical trials as described below :

• Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.
• Timeline Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
• Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, 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. Create and monitor the grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners, on trial-level budget status and changes.
• Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs) / Affiliate Study Training (ASTs) / Investigator Engagement Meetings.
• Drive and coordinate local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including issue management, contingency planning and resolving issues.
• Be accountable for trial / regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET)
• Partner with the Investigator Engagement organization to achieve regional enrollment goals.
• Manage relationships and serve as a single point of contact and central owner for trial communication, to and from the Clinical Design and Delivery organization, all cross functional team members, and vendors.
• 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 improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Manage vendor 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 clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.

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.

Minimum Qualification Requirements

Bachelors degree and preferably, prior experience in scientific or health related field. 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) for this employment position.

Highly Desired Skills

Advanced degree (e.g. MSc, PhD) in a scientific or health care field. Experience in clinical research experience or relevant clinical trial experience preferred. Applied knowledge of trial execution methodology, processes and tools. Demonstrated ability to work cross-culturally with global colleagues and with TPOs. Ability to influence without authority. Strong analytical skills. Strong leadership and networking skills exhibited while working in cross-functional and cross-cultural teams (internal & external) and on projects. Effective and influential communication, self-management, and organizational skills. Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity. Flexibility to adjust to altered priorities. Strong teamwork and interpersonal skills. Ability to develop and apply creative solutions. Curiosity and flexibility to learn new systems, processes and ways of working.

Other Information / Additional Preferences :

Limited travel to AST / ISST / Investigator Engagement meetings and other scientific or regional symposiums (5% or less)

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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $148,500. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees.