Associate Director - Regional Clinical Research Lead

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 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 Regional Clinical Research Lead (rCRL) leads the execution of clinical trials across a country/region/ globally 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 across the country / region(s) / globe. The rCRL is responsible to identify and execute process improvement opportunities using their understanding of cross functional interdependencies to enable end to end delivery of clinical programs. This rCRL role is based in and responsible for the United States region with a focus on Cardiometabolic Health (CMH) therapeutic areas.

Primary Responsibilities:

Clinical Trial Leadership

• Accountable to gather the insights and represent the geographical complexity and leads the coordinated effort for delivery of large, complex and high priority programs within countries / regions / globally

• Leverage deep expertise in regional trial execution to represent Investigator Engagement in cross functional clinical trial forums. Recognized as a Leader in Clinical Development, influencing study design and delivery and leads initiatives to drive improvements and deliver the portfolio

• Anticipate, mitigate and resolve complex and key operational risks, driving to enable timely delivery of clinical trial enrollment commitments and database locks across a country/region or portfolio

• Regional Leadership for inspection preparation and management. Proactively identify and drive for inspection readiness at all times.

• Leverage deep scientific and disease expertise within a TA (s), understand regional and local treatment paradigms and patient access mechanisms to influence platform/protocol decisions to enable reliable enrollment and implementation.

• Use insights from a broad range of sources including vendor oversight, best practices and metrics to identify and deliver functional process improvements.

• Utilize strategic knowledge of the Lilly portfolio and priorities to lead targeted prospecting and anticipate future needs for Investigator engagement.

Clinical Investigator Management:

• Leads CRLs in comprehensive Investigator management activities, including Investigator identification, qualification and selection, enrollment readiness, planning and execution through to database lock and close out for complex trials and portfolios across a country/region. Ownership for key hospitals / institutions / networks

• Independently detects and leads potential opportunities to accelerate trial enrollment across a country/region/ globally. Proactively identifies risks and implements mitigations to ensure Investigator performance and Clinical Trial delivery

• Leverages deep scientific, therapeutic area, and institutional/regional expertise to engage in scientific discussions with the investigator and institution personnel within a country / region 

• Owns strategic institutional/ Investigator relationships to optimize the delivery of clinical trial programs, including across therapeutic areas where applicable

Business Management and External Influence:

• Lead across portfolio / program to establish and develop strong professional relationships to expand/maintain clinical research partnership opportunities

• Understand cross functional interdependencies and identify opportunities for collaboration and process improvement, enabling end to end delivery of clinical programs

• Drive required interactions between external and internal partners (inclusive of affiliate and regional interactions and initiatives as applicable)

• Identify long and short-term customer, competitive and environmental trends and develop solutions to meet changing needs of customers and the business

• Identify and lead mechanisms for sharing of technical, scientific, and operational expertise with a broad focus to build Investigator Engagement capability and knowledge within the CDDA

• Coach & mentor roles within the CDDA organization

• Engage with Regulatory bodies, Ethical Review Boards, and other relevant external bodies to influence and challenge internal and external factors shaping clinical trial execution.  Ensure internal processes and procedures reflect and comply with country requirements.

• Influence internal and external customers/partners to identify opportunities and implement strategies for improving technologies, processes, products, and services.

Minimum Qualification Requirements:

• 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 role) and 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, set personal priorities and adjust as needed

• Demonstrated strategic agility & broad business acumen

• Demonstrated leadership behaviors with ability to accept challenges, seek opportunities to remove barriers, influence without authority, and lead in areas of uncertainty

Other Information/Additional Preferences:

• Strong communication (both verbal and written) and language skills to break down complexity into clear and concise messaging

• Demonstrated ability to enhance/improve customer experience

• Fluent in English as well as required language to conduct day-to-day business

• Strong teamwork and interpersonal skills, including ability to work in cross-cultural teams

• Demonstrated decision-making ability

• Ability to identify, develop and implement creative solutions

• Travel required (up to 50%)

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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