Associate Director - Clinical Development

Eli Lilly • Indianapolis, IN

307d • $118,500 - $173,800

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. Position Summary: The Associate Director Clinical Development will provide direction, leadership and technical/process expertise to their staff, execute integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team. The Associate Director Clinical Development will achieve this through clinical development expertise and effective partnership, and lead the asset/indication clinical team who are responsible for the execution and delivery of the clinical package.

Requirements

• Bachelor's degree, preferably in a scientific or health-related field.
• 5+ years of experience in the pharmaceutical industry and/or clinical development.
• Qualified applicants must be authorized to work in the United States on a full-time basis.

Nice To Haves

• Project Management certification (e.g., PMP).
• Must understand clinical 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 clinical trials with a strong knowledge of regulations and guidelines.
• Strong communication skills; able to communicate clearly and succinctly with team members and leadership.
• Must be capable of managing staff virtually and across geographies/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).
• Previous supervisory experience.
• 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.

Responsibilities

• Recruit, develop and retain a diverse and highly capable workforce.
• Build an organizational culture that fosters inclusion.
• Support and encourage talent identification, development and retention that reflects an end-to-end process approach and demonstrates judgement-based decision making.
• Ensure robust training plan and timely completion of required training for team.
• Responsible for clinical development of the assigned compound and/or indication from asset strategy through submission, inspection, approval and post-launch support.
• Collaborates with the cross-functionally to accelerate execution of the complete trial package (scope, timeline, budget and risk management).
• Lead the global clinical submission strategy, including scope, timeline, resource and risk management.
• Ensures collaboration with clinical design and clinical trial lead and other cross-functional team members for effective transition of clinical trial package to execution and clinical delivery.
• Responsible for execution and delivery of the global clinical submission plan, including communications to team and leadership, resource and risk management.
• Responsible for implementing clinical plan/trial to the approved timeline; ability to understand the critical chain methodology and use its functionality to manage program/trial.
• 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 compound and or indication-level.
• Handles global cross-functional communication and critical issues to ensure alignment on delivery and execution.
• Uses regulatory and process knowledge to drive decision making.
• Establishing and handling partner expectations, performance and delivery (i.e. CRO, Alliances and Joint Ventures).
• Align cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas.
• Ensure Clinical Development Trial Lead Competencies evolve and address implications to overall resource management and strategies.
• Maintains a state of inspection readiness for clinical development inclusive of TMF.
• Models judgement-based decision-making to navigate compliance and quality requirements.
• Responsible for continuous improvement in the following: clinical development, complete trial packages from the Clinical Design and process improvements to process owners in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work.

Benefits

• 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.
• 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: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree