Associate Director, Clinical Development Trial Lead (CDTL)

About the Role

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. As the Associate Director, Clinical Development Trial Lead (CDTL), you will independently lead the cross-functional study team in the development and execution of complex clinical trials, accountable both regionally and globally to deliver clinical milestones with quality, on time, and within scope and budget. This role requires independent leadership, influence across study teams and business partners, and proactive issue identification and resolution.

Responsibilities

• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT):
  • Scope: Understand the scope of work required to complete the clinical trial successfully. Monitor status and make adjustments as needed to meet deliverables.
  • Timeline: Develop and track the global trial enrollment plan by integrating inputs across functions and geographies. Provide consultation and guidance to other CDTLs on their integrated plans.
  • Risk: Assess, identify, and monitor trial-level risks.
  • Budget: Understand cross-functional, trial-level budget components. Create and monitor budget grants and non-grants using financial tracking tools. Network with business partners on budget status and changes.
• Lead, influence, and project manage large, complex studies and/or multiple smaller studies.
• Partner with organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs) and Affiliate Study Training (ASTs).
• Independently drive and influence local, regional, and global cross-functional study teams throughout study implementation, execution, and closure, empowering them to meet deliverables, including proactive issue management and contingency planning.
• Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
• Partner with Regional Operations to achieve regional enrollment goals.
• Anticipate and resolve complex technical operational or business problems with cross-functional teams (vendors, affiliates, global team members, and business partners) with minimal management support. Escalate issues as needed.
• Identify and assist in developing continuous improvement activities based on industry, regulatory, or technological trends.
• Make timely decisions for ambiguous and complex situations using expertise.
• Manage Third Party Organization (TPO) qualification, selection, and oversight.
• Serve as the Clinical Research Organization (CRO) clinical development point of contact for outsourced trials. Ensure CRO delivery of project milestones.
• Leverage broad therapeutic, clinical drug development, and process expertise to influence study design and program-level decisions, considering regional needs.
• Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial.
• Expand and deepen clinical trial process expertise across functional teams, regions, and external partners.
• Coordinate and facilitate regional input for study teams, ensuring alignment with the global and regional operating model.
• Serve as the single point of accountability for the Trial Master File for assigned trials, ensuring it is current and inspection-ready.
• Ensure inspection readiness of respective clinical trials, including timely documentation of deviations and creation of storyboards or issue summary documents.
• Network and apply expertise to anticipate trial and regional issues, propose innovative solutions, and share process learnings.
• Contribute to the development of others by coaching peers, new CDTLs, cross-functional team members, and TPOs on clinical trial processes and regional specificities.
• Identify and lead process improvement activities, acting as a subject-matter expert in the development and rollout of new tools and methodologies.
• Report, manage, and interpret information for clinical trials, ensuring completeness and accuracy across multiple business systems and tools.
• Drive regional clinical operational processes and methodologies.
• Apply expertise in global/regional regulations, Good Clinical Practice (GCP), and Lilly standards of operation in the conduct of clinical trials.
• Liaise with affiliates to understand local regulatory requirements.
• Independently detect and resolve quality issues, escalating to functional leadership or consulting other functions (e.g., Medical Quality, Legal, Compliance) as needed.
• Leverage scientific and regulatory knowledge to prepare clinical and regulatory documents, provide technical consultation, and draft responses to questions from regulatory agencies, TPOs, and affiliates.
• Combine scientific, regional, and operational knowledge to impact clinical trial design, feasibility, and implementation.
• Support the scientific needs of the business using clinical development knowledge, problem-solving, and critical thinking skills.
• Serve as the point of contact for Therapeutic Area and/or disease state expertise for others on the clinical team.

Requirements

• Bachelor’s degree (scientific or health-related field preferred).
• 5+ years of clinical research experience or relevant experience in a scientific or health-related field.
• Authorization to work in the United States on a full-time basis (Lilly will not sponsor work authorization or visas for this role).
• Onsite requirement at our Stamford, CT or Indianapolis, IN location. Relocation assistance available for qualified candidates.

Skills

• Experience with oncology (early phase clinical trials highly preferred).
• Experience with radioligand therapy (RLT).
• Applied knowledge of project management methodology, processes, and tools.
• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and TPOs.
• Recognized leadership with demonstrated ability to coach others in process expertise.
• Ability to embrace strategic organizational changes and lead others through them, exhibiting flexibility to adjust to frequent changes and altered priorities.
• Ability to influence without authority.
• Previous experience working in cross-functional teams/projects and/or ability to establish and maintain relationships.
• Effective and influential communication, self-management, and organizational skills.
• Demonstrated ability to handle complex situations through problem-solving, critical thinking, and navigating ambiguity.
• Minimum of 5 years of clinical trial experience with a strong working knowledge of the clinical research process.
• Prior clinical trial site-level or affiliate experience.
• Prior experience with local/country regional requirements.
• Strong analytical skills.
• Proficiency in project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI).
• Periodic travel to scientific/regional meetings required.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits.
• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $122,250 - $179,300. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).