Associate Director, CMC Project Management

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.
• Led the creation, development, communication and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.
• Leverage 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.

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.