Associate Director, CMC Project Management

Position Summary

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.

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.
• Leverage portfolio knowledge and development/financial acumen to enable investment strategy optimization at both project and portfolio level.
• Lead the creation, development, communication and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.
• 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.

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.