Role Summary
The Associate Director - Regional Clinical Research Lead (rCRL) leads the execution of clinical trials across a country/region/global for complex and high-priority programs to enable global clinical trial delivery. The rCRL anticipates, mitigates and resolves risks to ensure timely delivery of clinical trial enrollment. Based in the United States region, with a focus on Cardiometabolic Health (CMH) therapeutic areas.
Responsibilities
- Clinical Trial Leadership
- Accountable to gather insights and represent geographical complexity, leading the coordinated effort for delivery of large, complex, high-priority programs within countries/regions/global.
- Leverage regional trial execution expertise to represent Investigator Engagement in cross-functional clinical trial forums; influence study design and delivery and lead initiatives to drive improvements and deliver the portfolio.
- Anticipate, mitigate and resolve complex operational risks to enable timely delivery of enrollment commitments and database locks.
- Regional leadership for inspection preparation and management; drive inspection readiness at all times.
- Leverage scientific and disease expertise within therapeutic areas to influence platform/protocol decisions for reliable enrollment and implementation.
- Use insights from vendor oversight, best practices and metrics to identify and deliver process improvements.
- Utilize strategic knowledge of the Lilly portfolio to lead targeted prospecting and anticipate future Investigator engagement needs.
- Clinical Investigator Management
- Lead CRLs in Investigator management activities, including identification, qualification and selection, enrollment readiness, planning and execution through to database lock and close-out for complex trials across a country/region.
- Identify opportunities to accelerate trial enrollment and implement mitigations to ensure Investigator performance and trial delivery.
- Engage in scientific discussions with investigators and institutional personnel within a country/region.
- Own strategic institutional/Investigator relationships to optimize delivery of clinical trial programs across therapeutic areas.
- Business Management And External Influence
- Lead across portfolio/program to establish and develop professional relationships to expand/maintain clinical research partnerships.
- Understand cross-functional interdependencies and identify opportunities for collaboration and end-to-end delivery of programs.
- Coordinate interactions between external and internal partners (including affiliate and regional interactions).
- Identify long and short-term customer, competitive and environmental trends and develop solutions to meet changing needs.
- Share technical, scientific, and operational expertise to build Investigator Engagement capability within the organization.
- Coach and mentor roles within the organization; engage with regulatory bodies and ethics boards to ensure processes comply with country requirements.
- Influence internal and external customers to identify opportunities and implement strategies for improving technologies, processes, products, and services.
Qualifications
- Bachelor’s degree or equivalent in a scientific or health-related field
- Minimum of 5 years’ experience in the pharmaceutical industry and/or clinical research, including 3 years as a CRL (or equivalent) with strong working knowledge of Good Clinical Practice
- Deep therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain additional therapeutic expertise to support portfolio needs
- Proficiency in country regulatory guidelines/requirements
- Strong self-management and organizational skills; ability to manage workload and set priorities
- Demonstrated strategic agility and broad business acumen
- Demonstrated leadership behaviors with the ability to navigate challenges, influence without authority, and lead in uncertainty
Education
- Bachelor’s degree or equivalent in a scientific or health-related field
Additional Requirements
- Strong verbal and written communication skills; ability to convey complexity clearly
- Demonstrated ability to enhance customer experience
- Fluent in English and the required language for day-to-day business
- Strong teamwork and interpersonal skills; ability to work in cross-cultural teams
- Demonstrated decision-making ability and creative problem-solving
- Willingness to travel up to 50% (travel may be operationally required)