Full Job Description
Purpose:
The Clinical Development Program Lead (CDPL) is the single point of accountability for the cross-functional global clinical development of a given asset or portfolio of assets. As such, the CDPL ensures asset profiles and strategies are developed and clearly defined and leads effective and efficient development and delivery of asset clinical plans. The CDPL achieves this through strong partnerships and influence with asset team leadership (e.g. team leader, COO, medical director, lead CRP) and cross-functional team members from across the CDDA. The CDPL is accountable for developing and maintaining expertise in their therapeutic area including current and evolving clinical paradigms and knowledge of the competitive landscape. The CDPL is also accountable for high quality, efficient execution of the clinical plan, including proactive operational risk management, tracking progress-to-plan, and identifying acceleration opportunities. Finally, the CDPL is accountable for managing cross-functional support of key clinical deliverables in support of submissions, inspections, and publications.
The Clinical Development Program Lead reports to the Associate Vice President within their assigned therapeutic area.
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 include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Clinical Planning
37Single clinical development point of accountability for assigned asset(s) from strategy and profile development through to submission, approval and post-launch support.37Collaborates 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.37Identifies and supports novel development approaches that have the potential to accelerate the development of assets.37Champions 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.37Demonstrates strong business acumen, problem-solving skills, and agility to help team plan for contingencies, and adjust to changes.37Demonstrates a strong understanding of clinical paradigms and the external competitive landscape and how competitor trials are designed, etc.
Clinical Execution/Clinical Delivery
37Partners 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.
37Ensures the risk plans are developed and maintained during clinical plan implementation in response to new data and changes in the environment.37Promotes cross-functional and cross-phase collaboration to drive efficient implementation.37Represents clinical functions at asset team core meetings. Ensures streamlined and efficient project and meeting management. 37Accountable for budget planning, monitoring and control of the overall clinical plan and budget 37Documents and communicates key decisions, actions, and modifications in clinical scope, resources, timeline and risks.
Demonstrated Leadership and Influence
37Communicates and aligns cross-functional resources based on portfolio prioritization inclusive of being flexible across therapeutic areas.37Maintains compliance culture and a state of inspection readiness for clinical research activities.37Models judgement-based decision making to navigate compliance and quality requirements.37Responsible for identification of continuous improvement opportunities in the spirit of streamlining the efficiency and effectiveness of conducting clinical trials and non-trial work.
37Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development.37Creates and models an inclusive culture to ensure diverse voices/ideas are considered.37Serves as mentor for clinical development managers, clinical trial project managers and others in the CDDA.
People Management (as applicable, may be variable over time)
37Recruit, develop, and retain a diverse and highly capable workforce.37Ensures appropriate oversight of team deliverables through streamlined and efficient project management.
Minimum Qualification Requirements:
37Bachelor's degree, preferably in a scientific or health-related field37Minimum of 8 years' experience in the pharmaceutical industry and/or clinical research 37Broad understanding of the pharmaceutical drug/device development process37Prior experience in managing complex/cross-functional projects, and/or clinical trials37Experience with managing development budgets.37Qualified 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
Other Information/Additional Preferences:
37Post-graduate degree, e.g., Pharm D, M.S., or Ph.D.37Early oncology Clinical Development experience372 years previous supervisory experience (as applicable)37A strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.37Demonstrated ability to take and defend tough/unpopular positions37Prior project management experience and/or experience leading with multi-disciplinary team 37Demonstrated ability to take strategic knowledge and effectively influence the direction of daily operations37This is not a Remote based role. Candidates will be required to work onsite at either our Stamford, CT facility or Corporate Center in Indianapolis, IN, in a hybrid capacity. Relocation assistance can be provided
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$172,500 - $288,200
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.