Associate Director - Clinical Development (Oncology)

Eli Lilly and Company • Us, IN

15d

About The Position

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. Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the glob e by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Purpose The Clinical Development Associate Director is responsible for executing integrated clinical development plan s ( i.e. compound/indication-level) and clinical trial packages that are ali gned with the asset team . This will be achieved through clinical development expertise and effective partnership with the Clinical Development Senior Director/Executive Director , Asset Team and Desig n Hub. The AD will lead the asset/ indication clinical team who are responsible for the execution and delivery of the clinical package. They will also provide direction, leadership and technical/process expertise to their staff. I n partnership with Clinical Development Senior Director/Executive Director they also will model and reinforce the leadership behaviors and ensure career development of staff. Primary Responsibilities This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may in cl ude additional responsibilities not specifically described in the job description.

Requirements

• Bachelor's degree, preferably in a scientific or health-related field
• Minimum of 5 years' experience in the pharmaceutical industry and/or cl i n i c a l development
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

• Must understand cl i n i c a l development processes and the interdependencies of various tasks that require coordination among asset team, design hub, functional/regional team members and third parties
• Demonstrated core project management skills through management of complex/cross-functional projects, and/or cl i n i c a l t r i a l s with a strong knowledge of regulations and guidelines
• Strong communication skills; able to communicate cl early and succinctly with team members and leadership
• Must be capable of managing staff virtually and across g eo graphies/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)
• Project Management certification (e.g., PMP)
• Previous supervisory experience strongly preferred
• 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 ma y be

Responsibilities

• Responsible for cl i n i c a l development of the assigned compound and/or indication from asset strategy through submission, inspection, approval and post-launch support.
• Collaborates with the C l i n i c a l Development Senior Director/Executive Director , Asset Team and Design Hub to accelerate execution of the complete trial package (scope, timeli ne, budget and risk management).
• Lead the global cl i n i c a l submission strategy, in cl uding scope, timeline , resource and risk management.
• Ensures collaboration with Design Hub and CDTL and other cross-functional MDU team members for effective transition of clinical trial package to execution and clinical delivery .
• Responsible for execution and delivery of the global cl i n i c a l submission plan, in cl uding communications to team and leadership, resource and risk management .
• Responsible for executing cl i n i c a l plan/trial to the approved timeline; ability to understand the critical chain methodology and use its funct ionality to manage progra m/trial; ability to make updates to the critical chain in PRISM .
• Manages risks plans at the indication /trial-level during the implementation in response to new data and changes in the environment .
• Responsible for budget planning, monitoring and control of the total trial budget at the indication-level; works closely with the CDTL s who are responsible for the trial-level grants and nongrants budgets and rolls-up budget information to Clinical Development Senior Director/Executive Director who is accountable for the total clinical plan budget.
• Responsible for completing the cl i n i c a l assumptions within the UAT (unified assumptions tracker) , attending PFA/PSE meetings, and ensuring that the total trial budgets are accurate .
• Manages global cross-functional communication and escalations to ensure alignment on delivery and execution.
• Utilizes r egulatory and process knowledge to drive decision making .
• Establishing and managing partner expectations, performance and delivery ( i.e. CRO, Alliances and Joint Ventures) .
• Align cross-functional resources based on portfolio prioritization in cl usive of being flexible across therapeutic areas .
• Ensure Study Manager Competencies evolve and address implications to overall resource management and strategies .
• Maintains a state of inspection readiness for cl i n i c a l development in cl usive of TMF.
• Models judgement - based decision - making to navigate compliance and quality requirements .
• Responsible for continuous improvement in the following: cl i n i c a l development, complete trial packages from the design hub and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conducting cl i n i c a l t r i a l s and no n -trial work.
• Recruit, develop and retain a diverse and highly capable workforce
• Build an organizational culture that fosters in cl usion
• Support and encourage talent identification, development and retention that reflects an end-to-end process mindset and demonstrates judgement-based decision making .
• Ensure robust training plan and timely completion of require d training for direct reports.

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level