Associate Director - Clinical Research Lead

Job description

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. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. About Lilly At Lilly, everything we do starts with patients. We unite caring with discovery to make life better for people around the world. Headquartered in Indianapolis, Indiana, our global team of over 50,000 employees work with urgency and purpose to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. We bring our best to this work because people depend on it. If you’re driven by purpose and determined to make a meaningful difference for patients, we invite you to bring your skill and your commitment to Lilly. About Lilly’s India Affiliate Few careers offer the opportunity to work directly for the people your work is ultimately meant to serve. Lilly’s India affiliate is one of them. Whether you are building brand strategies, developing sales capabilities, creating market access, or enabling the teams that do — the work you do here ensures that Lilly’s medicines reach the people who need them. Job Description The Clinical Development Consultant (CRL) is responsible for the management of clinical sites being considered and/or participating in Lilly clinical trials; inclusive of site identification and qualification, the timely delivery of clinical trial enrollment in accordance with scientific objectives, timely delivery of database locks, issues management at clinical trial sites, and ensuring inspection readiness at all times for assigned therapeutic area(s) within a region/country that enables global program delivery. This is achieved by the CRL’s accountability for comprehensive site management, leveraging of information/tools to make/have informed decisions and discussions, and high-quality interactions with global clinical trial sites to drive to an unparallel customer experience. The CRL is also responsible for oversight of vendor monitoring activities at clinical trial sites, including the identification, mitigation and escalation of significant findings and trends. Additional local responsibilities may be required as needed/appropriate for the local geography. Clinical Investigator Management - Accountable for activities required at clinical trial sites and by investigators and site staff participating in Lilly trials; inclusive of site identification and qualification, enrollment planning and execution, to database lock and close out - Accountable for comprehensive site management activities to ensure timely delivery of enrollment readiness, trial recruitment/enrollment and database locks; inclusive of performance management and issue mitigation, identification and resolution - Responsible for identifying potential opportunities to accelerate trial enrollment, while driving to an unparalleled clinical trial/customer experience - Accountable for the application of scientific, therapeutic area, and institutional/regional expertise to inform and ensure timely delivery of trial enrollment and quality data - Accountable for the development of strategic institutional/site relationships to optimize the delivery of clinical trial programs; including across therapeutic areas where applicable Clinical Trial Management - Responsible for the development and implementation of applicable site risk plans to ensure delivery of clinical trial enrollment commitments and database locks - Ensure site and country level inspection readiness at all times - Leverage metrics to inform site/country/regional level decision making - Work with internal and external teams to remove barriers to trial execution at a site and/or country level - Responsible for understanding local treatment paradigms and standard of care to support targeted feasibility and strategic allocation of trials as required - Provide vendor oversight for site monitoring activities at site/country level Business Management and Engagement - Establishes and develops strong professional relationships with active/potential clinical investigators to expand/maintain clinical research partnership opportunities and provide an unparalleled experience for participation in Lilly clinical trials - Cross functional collaboration and partnership to ensure alignment in priorities and deliver the portfolio - Perform targeted sites prospecting in alignment with portfolio strategy & priority - Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel - Serve as an effective communication ‘bridge’ between sites, third party vendors and Lilly - Influence and challenge internal and external factors in order to improve clinical research delivery Minimum Qualification Requirements - Bachelor’s degree or equivalent - Minimum of 8–10 years’ experience in the pharmaceutical industry and/or clinical research and strong working knowledge of Good Clinical Practice - Therapeutic expertise and knowledge of the clinical research landscape; ability to acquire and maintain therapeutic expertise to support portfolio needs - Strong self-management and organizational skills; ability to manage workload, set personal priorities and adjust as needed - Demonstrated strategic agility & broad business acumen - Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, influen