Associate Director, CMC Project Management

Lilly • Indianapolis, IN

2d • $115,500 - $169,400 • Onsite

About The Position

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.

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.

Nice To Haves

• 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.

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.

Benefits

• company bonus
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level