Senior Clinical Development Program Lead

Eli Lilly and Company; Indianapolis (IN); On-site; USD 117,000 - 172,000; Full time

Job summary

Lilly is seeking a Program Lead, Clinical Delivery in Indianapolis to lead exploratory and biopharmaceutics clinical development plans at the molecule level. You will oversee global trial operations, timeline creation, outsourcing plans, vendor oversight, and budget management across the development plan.

You will partner with regulatory, medical, and cross-functional teams to ensure safety monitoring and timely delivery of milestones, while coaching and mentoring team members and managing risk.

Qualifications

• Bachelor’s degree in a science related field from an accredited college or university.
• 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, exploratory and/or biopharmaceutics clinical development.
• Experience with regulations and guidelines that apply to the conduct of clinical trials.
• Leadership experience.
• Experience overseeing TPOs to enable delivery of trial level deliverables.
• Experience with project management tools and processes.
• Experience working cross-culturally and in a virtual work environment.
• Ability to travel (up to 10% expected).

Responsibilities

• Leads the development of the clinical asset strategy for phase 1 leveraging quality decision making principles.
• Understands assigned therapeutic area including trial designs, risks and execution challenges and best practices.
• Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications, and manuscripts.
• Stays up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.
• Maintains knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions.

Skills

Leadership

Communication

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in a science related field

Tools

Word

Excel

PowerPoint

Microsoft Project

Job description

Lilly is seeking a Program Lead, Clinical Delivery in Indianapolis to lead exploratory and biopharmaceutics clinical development plans at the molecule level. You will oversee global trial operations, timeline creation, outsourcing plans, vendor oversight, and budget management across the development plan.

You will partner with regulatory, medical, and cross-functional teams to ensure safety monitoring and timely delivery of milestones, while coaching and mentoring team members and managing risk.