Sr. Director - Clinical Development Program Lead (CDPL) - Early Oncology

Primary Responsibilities

• Single clinical development point of accountability for assigned asset(s) from strategy and profile development through to submission, approval and post-launch support.
  • Collaborates with and influences asset teams to create competitive profiles and partners across the CDDA to ensure the creation of viable clinical scenarios.
  • Drives communication of options with the asset team and clinical plan decision making.
  • Identifies and supports novel development approaches that have the potential to accelerate the development of assets.
  • Champions the asset strategy and drives translation of the strategy to the Clinical Development Trial Lead staff.
  • Ensures that all clinical functions understand the strategy, timelines and risks.
  • Demonstrates strong business acumen, problem-solving skills, and agility to help team plan for contingencies, and adjust to changes.
  • Demonstrates a strong understanding of clinical paradigms and the external competitive landscape and how competitor trials are designed, etc.
• Clinical Execution/Clinical Delivery
  • Partners across the CDDA to ensure delivery of the complete trial package (scope, timeline, budget and risk management) that enables the rapid transition into trial execution.
  • Safeguards the risk plans are developed and maintained during clinical plan implementation in response to new data and changes in the environment.
  • Promotes cross-functional and cross-phase collaboration to drive efficient implementation.
  • Represents clinical functions at asset team core meetings.
  • Ensures streamlined and efficient project and meeting management.
  • Documents and communicates key decisions, actions, and modifications in clinical scope, resources, timeline and risks.
• Leadership and Influence
  • Communicates and aligns cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas.
  • Maintains compliance culture and a state of inspection readiness for clinical research activities.
  • Models judgement-based decision making to navigate compliance and quality requirements.
  • Identifies continuous improvement opportunities in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work.
  • Serves as mentor for clinical development managers, clinical trial project managers and others in the CDDA.

Minimum Qualification Requirements

• Bachelor’s degree, preferably in a scientific or health-related field.
• Minimum of 8 years’ experience in the pharmaceutical industry and/or clinical research.
• Broad understanding of the pharmaceutical drug/device development process.
• Prior experience in managing complex/cross-functional projects, and/or clinical trials.
• Experience with managing development budgets.

Other Information/Additional Preferences

• Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.
• Early oncology Clinical Development experience.
• 2 years previous supervisory experience (as applicable).
• A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Demonstrated ability to take and defend tough/unpopular positions.
• Prior project management experience and/or experience leading with multi-disciplinary team.
• Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations.

Actual Compensation

• The anticipated wage for this position is $172,500 - $288,200.

Benefits

• Full-time equivalent 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).