Associate Director, CMC Project Management

Associate Director, CMC Project Management

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.

The Associate Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible for leading the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.

Responsibilities:

• Effectively partner with global program team/governance and translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams for programs of moderate complexity. Lead the creation, development, communication and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. Leverages portfolio knowledge and development/financial acumen to enable investment strategy optimization at both project and portfolio level. The Associate Director, CMC Project Management may also partner with the Senior Director or Assoc. VP, CMC Project Management to deliver high complexity programs.
• Drive cross-functional CMC teams to maximize the value of data, create bold/competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions.
• Know when and how to appropriately raise issues to team and to stakeholders. Keep both team members and stakeholders fully apprised of project status and issues at the right level of detail.
• Leverages AI tools and emerging technologies to streamline CMC project planning, accelerate cross-functional decision-making, and drive continuous improvement in team productivity.
• Develop high performing matrix teams with an ability to quickly identify gaps in team effectiveness and implement remediation efforts to ensure project success.
• Support Due Diligence efforts by leading CMC plan development and integrating/communicating key findings with LRL/BU/M&Q stakeholders.
• Participate in or lead continuous improvement projects, which can significantly impact the work and/or effectiveness of CMC development. These projects can be cross divisional and relate to optimizing capabilities, systems, and processes for divisions and/or portfolio.

Basic Requirements:

• BS degree in a scientific or engineering discipline (e.g., chemistry, biochemistry, chemical engineering, pharmaceutical sciences, biology, or related field).
• 5+ years of drug development experience and good understanding of the different phases of development, associated CMC deliverables, and how the various functional areas contribute to a comprehensive strategy.
• Demonstrated ability to lead cross-functional team(s) and together solve complex problems.
• Demonstrated ability to rapidly become proficient in new tools.
• Demonstrated ability to communicate complex issues timely, precisely, and succinctly.

Preferred Education/Experiences:

• Advanced degree (Master of Science, Master of Business Administration, PharmD, Ph.D.).
• Global submissions/approvals experiences.
• Supervisory experiences.
• Practical experience (formal or informal) in project management of cross-functional projects.
• Project Management Professional (PMP) Certification.

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 for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.