Associate Director (Supervisor) - Investigator Engagement

Lilly • Indianapolis, IN

1d • Hybrid

About The Position

The Associate Director/Director, Investigator Engagement is responsible for leading and managing a team of Clinical Research Leads (CRLs; Investigator Engagement Team) within a defined geography, in this case the United States, and for collaborating with business partners to ensure clinical trials/studies across all therapeutic areas are executed in accordance with the scientific objectives, country-specific clinical trial strategy, timelines, budget, and local requirements. The Associate Director / Director, Investigator Engagement is accountable for ensuring consistent high quality interactions with, and timely robust performance of, global clinical trial sites and vendors. The Associate Director / Director, Investigator Engagement is also responsible for recruitment, training and development of the Investigator Engagement Team and CRLs who are responsible for comprehensive Investigator management, inclusive of the delivery of Investigator performance metrics, on time database locks, and inspection readiness. Additional local responsibilities may be required as needed/appropriate for the local geography. This position is specifically supporting the United States CRL field team with a focus on cardiometabolic heath.

Requirements

• Bachelor’s degree or equivalent work experience in a scientific field or health-related field
• 5 years experience in Clinical Trials/Development and good working knowledge of Good Clinical Practice
• Demonstrated direct-line people leadership skills with ability to influence, achieve results through others and lead across the business.
• Strong communication (both verbal and written) and language skills – ability to provide coaching to employees and communicate effectively up and down in the organization
• Demonstrated leadership/supervisory skills with ability to influence, achieve results through others and lead across the business.
• Experience with analytics/AI and data-driven process development
• Strong organizational/planning skills
• Fluent in English
• Strong knowledge in country regulatory guidelines/requirements
• Strong interpersonal skills and ability to build/foster strong partnership across functions
• Demonstrated decision-making ability
• Ability to develop and apply creative solutions
• Experience in working cross-culturally and with virtual teams
• Strong stakeholder management skill with ability to influence at senior levels

Responsibilities

• Accountable for clinical trial execution within the United States across the cardiometabolic health therapeutic area.
• Responsible for investigator qualification and enrollment performance
• Ensure on time delivery of database locks within the region/country (ies)
• Provide vendor oversight of delegated responsibilities for site monitoring activities of trial within the country (ies); drive routine discussions with a focus on performance, ensure milestone delivery with quality
• Leverage data-driven insights/analytics to accelerate site selection activities as well as site management.
• Understanding and knowledge of local treatment pathways to support targeted feasibility as required. Input into strategic allocation of trials as required
• Engage externally with all appropriate bodies (eg., MoH, ERBs, Pharma Associations) to understand country(ies) Clinical Trial regulatory environment(s) and ensure internal processes and procedures are maintained to reflect and comply with country requirements. Share with other functions as appropriate
• Drive real-time mitigation of issues and appropriate problem solving with proactive approach
• Manage Country Business planning and execution (Budget/capacity)
• Provide clear direction and align objectives of the Investigator Engagement Team with strategies for clinical development of portfolio assets
• Support flexibility of resources across therapeutic areas and geography (ies) while aligning to deliver on company priorities
• Responsible for development and implementation of applicable risk plans to ensure delivery of clinical trial enrollment commitments and database locks
• Drive a culture of high quality and inspection readiness
• Continuous monitoring of the performance / productivity of Investigator Engagement Team and identification of opportunities for improvement. Ensure implementation of affiliate and regional initiatives and shared learning as appropriate.
• Enable a culture of continuous improvement focused on outcomes, efficiency gains, and individual accountability
• Engage in the external clinical development community to influence external improvements, and drive the incorporation of external learnings into internal improvement efforts
• Seek opportunities to identify and apply innovative ideas and/or approaches within country (ies) of responsibility
• Effectively manage and coordinate an agile organization that continuously adapts to meet the needs of a changing portfolio
• Manage a diverse organization that fosters inclusion and innovation
• Coach CRLs and partner with rCRLs and TA leads to develop appropriate strategies to ensure positive customer experiences
• Establish performance plans, monitor and evaluate the performance of the CRLs
• Attract, develop and retain top talent in the Investigator Engagement organization

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees