Hybrid Associate Director-Trial Capabilities-Investigator Grants presso Lilly

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 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 their 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.

Primary Responsibilities:  

1. Clinical Trial Capabilities Responsibilities 

• 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. 
• Accountable for prioritization of work to meet portfolio needs. 
• Manage 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. 
• Create, communicate, and execute investigator and country level risk mitigation and contingency plans.
• Participate and perform duties required for internal and external inspections as well as supporting institutions and investigators in inspection readiness initiatives. 
• Continually strengthen the customer experience through innovative strategic solutions.
• Provides expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements. 
• Establish strong partnerships with Global TC Budgeting, Contracting and Grants partners and Lilly Legal to lead the execution of process optimization for clinical trial capabilities, including budgeting, contracting, patient reimbursement and grants management.

2. 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 Global TC and Lilly Legal to leverage technology to increase efficiency of clinical trial capabilities and resources.
• Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.
• Lead and collaborate with all applicable customers on process improvement projects by providing expertise and direct support to ensure completion and implementation. Develop and execute clear implementation and communication plans for new or revised processes. Ensure appropriate training and procedures are created, maintained, and governed for each process. 
• Develop and implement methods, mechanisms and tools to meet and measure customer satisfaction both internally and externally.

Minimum Qualification Requirements:  

• Bachelor’s degree preferably in a scientific or health related field, clinical research experience or related experience preferred

• Experience in coaching and mentoring others

• Understanding of the overall clinical development paradigm and the importance of efficient site initiation and management

• Applied knowledge of project management processes and skills

• Appreciation of / experience in compliance-driven environment

• Knowledge of and ability to follow financial and legal guidelines and policies (budget and contract)

Other Information/Additional Preferences:  

• Strong communication, negotiation, and problem solving skills

• Self-management and organizational skills

• Change management expert

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

$111,000 - $162,800

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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