Senior Director, CMC Project Management

Role Summary

The Senior 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 teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams.
• Lead the creation, development, communication, and implementation of integrated CMC plans for assets with the functional CMC areas from portfolio entry through global submissions, approvals, and launch.
• Leverage portfolio knowledge, development, and financial acumen to enable investment strategy and optimization at both project and portfolio level.
• 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.
• Understand when and how to appropriately raise issues to teams 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 plans while integrating and communicating key findings with stakeholders.
• Coach new PMs in the management of a development project: team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, processes relating to CMC development, strategic document preparation, and PM best practices.
• Participate in or lead continuous improvement projects, which significantly impact the work and/or effectiveness of CMC development.

Qualifications

• BS/BA degree, preferably in a scientific or engineering discipline
• 10+ years of drug development or combination product experience
• Must be succinct communicator with fluency in English (written and spoken)
• 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