Associate Director - Trial Capabilities at Eli Lilly and Company

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.

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

$118,500 - $191,400

The Associate Director (AD), Trial Capabilities will provide leadership in clinical trial capabilities in support of clinical development. The AD is accountable for the prioritization, planning and implementation of investigator initiation activities working closely with investigator engagement in the region and global design and delivery teams, ensuring accurate planning, prioritization, and timely execution to meet the regional portfolio needs. Through synergetic partnerships, accurate planning, and timely execution the AD will ensure all country and investigator level trial deliverables are accomplished.

The AD is accountable to ensure the investigators meet requirements to enroll study participants into clinical trials and support ongoing activities during maintenance and close-out. The AD drives results and efficiencies by providing leadership, direction, and technical support to the Trial Capabilities Team navigating the complexities of regulatory agencies, institutions’ and investigators’ budgets and contracts, informed consent negotiations, and other regulatory activities for the clinical trial as applicable to achieve regional goals and objectives. The AD will always ensure inspection readiness through a complete, accurate and readily available Trial Master File.

This role will support and develop a team of trial capabilities managers, associates and/or specialists, experts in investigator grants budgets, payments and supplementary roles to provide clinical trial capabilities in support of global clinical development.

Responsibilities:

• Accountable for establishing, obtaining and exceeding goals for clinical trial initiation for development programs.
• Accountable to lead team through investigator initiation, maintenance, and close out-activities in compliance with local/regional requirements, data privacy requirements and Lilly’s global quality standards.
• Drive and ensure Investigator Activation strategies are created and delivered.
• Lead communications/relationships and serve as the point of contact for the trial capabilities deliverable during investigator initiation, maintenance, and close out representing progress to business partners.
• Continually strengthen the customer experience through innovative strategic solutions
• Build collaborative partnership with key business partners, maintaining clear communication of progress through the delivery of all clinical investigator activities.
• Accountable for prioritization of work to meet portfolio needs.
• Ensure flexibility of resources across trial capabilities teams and geographies.
• Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
• Develop and manage strategies to improve customer experience.
• Accountable for inspection readiness through a complete, accurate and readily available Trial Master File
• Always maintain a state of inspection readiness. Participate and perform duties required for internal and external inspections as well as supporting institutions and investigators in inspection readiness initiatives.
• Develop strong partnerships with Investigator Engagement, Clinical Design, and Clinical Delivery Team members who will engage on investigator activity and performance at feasibility discussions during the life of the trial.
• Create, communicate, and execute investigator and country level risk mitigation and contingency plans.
• Provide expertise related to investigator grants processes and identify strategic levers to obtain cost savings and efficiency gains.
• Ensure the team operations in investigator grants and related operations are at a consistent high standard with issues resolved in a timely manner
• Closely partner with the team to ensure reporting & metrics are delivered to deadlines
• Drive the compliance agenda with the team and ensuring that the team understands the importance of compliance and the controls governing budgeting and grants processes.

Organizational Leadership

• Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDDA and LRL
• Build capabilities in the function through the development and improvement of processes, tools and training and partnering with Clinical Trial Foundations (CTF) and Tech@Lilly to leverage technology to increase efficiency of clinical trial capabilities and resources.
• Enable a culture of continuous improvement to drive efficiency through process improvement, communication skills, and shared learning

People Management and Development

• Recruit, develop, and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development, budget design, payments and customer service.
• Effectively manage an agile organization that continuously meets the needs of a changing portfolio
• Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery

Basic Qualifications:

• Bachelor’s degree, preferably in a scientific or health related field, or relevant experience preferred
• 5 years clinical research experience
• Understanding of the overall clinical development paradigm and the importance of efficient investigator initiation
• Previous supervisory experience
• Strong leadership skills and ability to influence others and lead across the business
• Project management processes and skills
• Appreciation of / experience in compliance-driven environment
• Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
• Self-management and organizational skills

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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