Job Information
Lilly Associate Director, CMC Project Managment in Indianapolis, Indiana
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.
Position Summary: The Associate Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC team(s) and will partner closely with the scientific and technical leaders of the CMC team, who are accountable 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.
Leverage portfolio knowledge, drug development, and 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.
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 development assessments, and integrate, stakeholder communication regarding key findings with LRL/Business Unit/Manufacturing and Quality leaders .
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/BA degree, preferably in a scientific or engineering discipline and 3+ years of drug development or combination product experience and good understanding of the different phases of development, associated CMC deliverables, and how the various functional areas contribute to a comprehensive strategy OR an MS/ PhD/PharmD in scientific, engineering or pharmacy discipline with some academic research experience.
Must be strong communicator with fluency in English (written and spoken)
Additional Preferences:
Advanced degree strongly preferred (MS, MBA, PhD or PharmD)
Understanding of development phases, associated CMC deliverables, and interactions of various functional areas and how each relates to a comprehensive strategy
Global submissions/approvals experience
Supervisory experience
Practical experience (formal or informal) in project management of cross-functional projects
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, accurately, and succinctly
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