Lilly Clinical Development Group Lead in Bengaluru, India
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 35,000 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 purpose of the role of the Clinical Development Group Lead is to manage a team of clinical trial project managers with respect to talent recruitment, performance management, and support for individual development and career path progression within Clinical Development (CD) at the Lilly Capability Center India(LCCI) as well as provide support for clinical trial planning and execution. The Group Lead will drive and support operations in LCCI ensuring successful integration and alignment to global organizational strategy and deliverables in collaboration with global clinical development staff.
People Related (25 to 50%, depending on # direct reports)
Ensure all direct reports have a performance management and a development plan in place.
Conduct PM reviews/check-ins to evaluate performance (including timelines and clear objectives), business results, and impact.
Provide appropriate input based on consensus evaluation for merit increase and promotion activities.
Contribute to the individual development of direct reports through administrative direction, coaching, mentoring, and timely feedback.
Appropriately manage the workload of direct reports; monitor project timelines and quality and communicate priorities to direct reports.
Provide input on employee development, talent assessment, and succession planning activities.
Encourage appropriate rewards for deserving individual/group performance and results.
Engage in activities supporting teambuilding and diversity.
Ensure all direct reports are in compliance with company policies, procedures and regulations.
Business Related and Clinical Trial Planning/Execution (50 to 75%, depending on # direct reports)
Perform appropriate staffing activities and support the training and integration of new and current staff.
Take active role and work with the team in capacity planning/business planning and have ownership of implementation/execution of the plans and priorities.
Prioritize work, assign resources as necessary, and escalate issues to teams and management as appropriate.
Communicate with business partners on progress of deliverables and risk mitigation strategies developed and implemented.
Contribute to process improvements, suggesting opportunities where appropriate.
Leverage project management skills, processes/tools, clinical development knowledge and leadership skills to develop and execute local, regional and/or global clinical trials as detailed in the Clinical Trial Project Manager (CTPM) job description.
Combine scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
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.
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.
Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools from study implementation through closure
Manage relationships and serve as a point of contact for trial communication to and from the Clinical Development, CDDA, and Third Party Organizations (TPOs).
Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalized, and owned by Clinical Development
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 and coach peers, cross-functional team members and TPOs on aspects of clinical trial process and regional specificities
Minimum Qualification Requirements:
Bachelor’s degree (or higher) in Healthcare/Life Science or equivalent demonstrated experience.
5 years drug development experience.
Strong verbal and written communication with ability to influence and collaborate across geographies.
Ability to work well across cultures and time zones.
Demonstrated project management and time management skills
Basic computer skills (Microsoft Word, Excel, Windows XP).
Ability to lead, motivate and coach to nurture talent and engagement.
Proactive and result oriented with ability to prioritize and multi-task.
Other Information/Additional Preferences:
Experience of managing teams/projects is preferred, especially in clinical development/clinical trial project management or related field and in a global environment.
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