Associate Director-Clinical Development-Immunology

Eli Lilly and Company • Us, IN

5d

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. Responsibilities: The Associate Director Clinical Development is responsible for executing integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team which will be achieved through clinical development expertise and effective partnership with the Senior Director/Executive Director Clinical Development, Asset Team and Clinical Design. The Associate Director Clinical Development will lead the asset/indication clinical team who are responsible for the execution and delivery of the clinical package and provide direction, leadership and technical/process expertise to their staff. The Associate Director Clinical Development in partnership with Senior Director/Executive Director Clinical Development will model and reinforce the leadership behaviors and ensure career development of staff. Primary Responsibilities Clinical Planning 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 Senior Director/Executive Director Clinical Development, Asset Team and Clinical Design 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. Clinical Execution Ensures collaboration with Clinical Design and Clinical Development Trial Lead (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 clinical submission plan, including communications to team and leadership, resource and risk management. Responsible for executing clinical plan/trial to the approved timeline; ability to understand the critical chain methodology and use its functionality to manage program/trial; ability to make updates to the critical chain. 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; works closely with the CDTLs who are responsible for the trial-level grants and nongrants budgets and rolls-up budget information to Senior Director/Executive Director Clinical Development who is accountable for the total clinical plan budget. Responsible for completing the clinical assumptions within the UAT (unified assumptions tracker), attending financial 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 regulatory and process knowledge to drive decision making. Establishing and managing partner expectations, performance and delivery (i.e. CRO, Alliances and Joint Ventures). Effective Management 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 the Trial Master File (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 no n -trial work. People Management 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 mindset and demonstrates judgement-based decision making. Ensure robust training plan and timely completion of required training for direct reports.

Requirements

• Bachelor's degree, preferably in a scientific or health-related field
• 5+ years in the pharmaceutical industry and/or clinical development
• 5+ years project management experience across the clinical trial landscape
• 3+ years managing a team of direct reports virtually and across geographies/cultures
• Experience managing clinical development processes and associate tasks
• Qualified candidates must be legally authorized to be employed in the United States.
• Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Nice To Haves

• Project Management certification (e.g., PMP)
• Previous supervisory experience
• Proven ability to coach and develop others
• 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
• 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)
• 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 may be required

Responsibilities

• Responsible for executing integrated clinical development plans (i.e. compound/indication-level) and clinical trial packages that are aligned with the asset team which will be achieved through clinical development expertise and effective partnership with the Senior Director/Executive Director Clinical Development, Asset Team and Clinical Design.
• Lead the asset/indication clinical team who are responsible for the execution and delivery of the clinical package and provide direction, leadership and technical/process expertise to their staff.
• In partnership with Senior Director/Executive Director Clinical Development will model and reinforce the leadership behaviors and ensure career development of staff.
• 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 Senior Director/Executive Director Clinical Development, Asset Team and Clinical Design 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 Development Trial Lead (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 clinical submission plan, including communications to team and leadership, resource and risk management.
• Responsible for executing clinical plan/trial to the approved timeline; ability to understand the critical chain methodology and use its functionality to manage program/trial; ability to make updates to the critical chain.
• 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; works closely with the CDTLs who are responsible for the trial-level grants and nongrants budgets and rolls-up budget information to Senior Director/Executive Director Clinical Development who is accountable for the total clinical plan budget.
• Responsible for completing the clinical assumptions within the UAT (unified assumptions tracker), attending financial 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 regulatory 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 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 the Trial Master File (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 no n -trial work.
• 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 mindset and demonstrates judgement-based decision making.
• Ensure robust training plan and timely completion of required training for direct reports.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees