Job title: Clinical Development Team Lead/Manager
Job description: Purpose: The Clinical Development Team Lead/Manager, provides supervision, leadership, and technical/process expertise for the clinical project management associates and assistants they supervise within the Clinical Development Organization. This pos
Purpose: The Clinical Development Team Lead/Manager, provides supervision, leadership, and technical/process expertise for the clinical project management associates and assistants they supervise within the Clinical Development Organization. This position provides strategic input, focuses on results, thinks critically, and emphas and drives cross-functional team collaboration. The CD Team Lead/Manager is responsible for managing a book of work through capacity and personnel management, staff recruitment and development, business planning, and cross-functional communication. The Team Lead will draw upon information from multiple internal and external sources to lead and provide technical coaching to the Clinical Development Group Lead (GL), Clinical Development Project Managers (CTPMs), and Clinical Development Project Management Assistants (CTPMAs) to ensure to ensure that trial-level planning and execution are in alignment with strategy and timelines for the asset. The Clinical Development manager is responsible for the quality delivery of the clinical trial portfolio that their staff leads. Additionally, the Clinical Development Team Lead/Manager will provide leadership with recruiting/onboarding, inspection readiness activities, process improvements, and diversity initiatives, etc. within the CDDA and will ensure career development plans are in place for their staff all while leading by example in the Team Lilly behaviors. The Team Lead/Manager will collaborate and influence teams and work closely with Clinical Development Managers and Team Leads across Clinical Development to ensure best practices across the function. Portfolio Management/Delivery Responsible/accountable for management/delivery of overall book of work for assigned area. Develops and executes sourcing plans in partnership with CD leads to ensure seamless delivery of asset plan and priorities. Collaborates with function, capability, and site leadership to ensure alignment of business planning and operations. Coordinates across and develops synergies with therapeutic areas, phases of development, and geographies. Adjusts work plan based on shifting priorities using effective change control. Leads and directs internal and external team members in achieving team goals. Identifies and resolves issues impacting delivery of work. Conceives and implements new and efficient ways to accomplish goals. Partners in the selection process and may manage relationship for preferred vendors. Regularly reports results of team activities/metrics to leadership and stakeholders Manage audit readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation. People Management and Development Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in clinical development and clinical trial project management Effectively creates and manages an agile organization that continuously meets the needs of a changing portfolio. Builds an organizational culture aligned with Team Lilly – inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people. Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management, and cross-functional leadership. Provide input on employee development, talent assessment, and succession planning activities. Develops an organizational talent base that demonstrates judgment-based decision making. Provides guidance, training, and supervision to personnel. Appropriately manage the workload of direct reports monitor project timelines and quality and communicate priorities to direct reports. Provide technical support and guidance to direct reports as needed. Evaluates performance by reviewing documents and attending writing team meetings and recommends developmental actions for all assigned staff. Ensure all direct reports are compliant with company policies, procedures and regulations. Subject Matter Expert/ Organizational effectiveness Leads development of new and emerging capabilities to support the effectiveness of Clinical Development. Functions as expert on document strategy, planning and execution, and industry standards and guidelines. Shares expertise with others. In partnership with others, develop, implement, and update Lilly policies, procedures, training, and tools that are compliant with industry guidelines. Minimum Qualification Requirements: Bachelor’s degree, preferably in a scientific or health-related field Minimum of 5 years’ experience in the pharmaceutical industry and/or clinical development Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines Strong communication skills able to communicate clearly and succinctly with team members and leadership Must be capable of managing staff virtually and across geographies/cultures Proven ability to coach and develop others Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity) Other Information/Additional Preferences: Project Management certification (e.g., PMP) Previous supervisory experience Prior experience in working with a non-Lilly business partner (e.g., CRO, Alliance, Joint Venture) Prior submission and inspection experience Prior experience with the management of business plans Strong self-management and organizational skills able to manage workload, set personal and team priorities and adjust as needed Able to influence others without direct authority Strong problem-solving skills, able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent reoccurrence Travel may be required
Location: Bangalore, Karnataka
Job date: Sat, 22 Jan 2022 23:09:34 GMT
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