Senior Associate / Manager, Clinical Development Trial Lead (CDTL)

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 Clinical Development Trial Lead (CDTL) Associate 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 deliverables.

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.

Trial Leadership, and Regional Operational Knowledge

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

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 issue resolution.

• Be accountable for trial/regional enrollment strategy and execution starting from country allocation through Last Patient Entered Treatment (LPET) o 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 Third Party Organization (TPOs).

• 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 clinical trial. Look for opportunities to expand and deepen clinical trial process expertise.

• Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams

• Single point of accountability for the Trial Master File, working closely with functional record owners to ensure the file is current and inspection ready at all times.

• 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 clinical trial.

• Demonstrate ability to lead and influence in the midst of ambiguity. • Coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities.

• Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical 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 clinical trial operational knowledge, and process expertise to impact clinical trial design, feasibility implementation, and execution.

• Utilize clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business and clinical programs

Minimum Qualification Requirements:

• Bachelors or University degree (scientific or health-related field preferred)

• 3 years clinical research experience or relevant clinical trial experience in a scientific or health-related field; or an advanced degree.

Highly Desired Skills:

• 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 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

Other Information/Additional Preferences:

Need to travel periodically to AST/ ISST/Investigator Engagement meetings and potentially other scientific or regional symposium

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 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). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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