Associate Director - Clinical Development Trial Lead (CDTL)

Primary Responsibilities

• Project Management, and Regional Operational Knowledge
• Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative Critical Chain network builds, providing input on strategy).
• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:
• Scope - Understand the scope of work required to complete the clinical trial successfully.
• Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their Integrated Plans.
• 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 budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items.
• Lead, influence and project manage large, complex studies and/or multiple smaller studies.
• Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
• Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program.
• Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)
• Partner with the Regional Operations to achieve regional enrollment goals
• Foster relationships and serve as a single point of contact and central owner for trial communication, to and from the CDDA Organization, Regional Clinical Operations, and Third-Party Organizations (TPOs). Effectively manage and influence upward.
• Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/ regions, global team members, and other business partners) with little/ no need for direct management support. Evaluate and determine issues that require escalation.
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Leverage expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-oriented approach to conducting daily business.
• Manage TPO (third party organization) qualification process, selection, and oversight.
• Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones.

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.
• Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.

Minimum Qualification Requirements

• Bachelor's or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Desired Skills

• Applied knowledge of project management methodology, processes and tools
• Fosters a culture of innovation by encouraging new perspectives, experimenting with ideas, and collaborating across teams to develop impactful solutions.
• Demonstrated utilization of process improvement ideologies
• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs
• Be recognized as a leader with demonstrated ability to coach others in process expertise.
• Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
• Effective and influential communication, self-management, and organizational skills
• Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity

Other Information/Additional Preferences

• Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
• Oncology background
• CAR-T background
• Prior clinical trial site-level or affiliate experience
• Prior experience with local/country regional requirements
• Strong analytical skills
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
• Leverages AI-powered tools and technologies to enhance productivity, streamline workflows, improve decision-making and drive operational efficiency