Associate Director - Clinical Development Program Lead, Clinical Delivery - EMP

JOB DESCRIPTION

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.

Purpose :

The purpose of the Program Lead, Clinical Delivery is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. The Program Lead, Clinical Delivery is responsible for planning and delivering exploratory and biopharmaceutics clinical trial and submission milestones on time and on budget throughout the molecule lifecycle.  The Program Lead, Clinical Delivery is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational deliverables), and budget management. The Program Lead will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities.

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.

Scientific and Therapeutic Area Expertise

• 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 e.g., FHD (First Human Dose) requirements, detail of operations to deliver critical path studies and submissions.

Clinical Project Management :

Clinical Delivery :

Communication and Team Management :

Leadership

For select Program Leads, Clinical Delivery – EMP, the following section will also apply

People Management

Minimum Qualification Requirements :

Other Information / Additional Preferences :

Job Description Version History :

Version Number

Description of Change

1.0

This is the initial release. This document replaces JD12275 that was retired in error.

2.0

Updated title and description

If you are using a printed copy of this document, make sure it is the most current approved version.

version.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$115,500 - $169,400

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.

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