About the role
Location Requirement:
This position can be located on the U. S. West Coast (preferably near San Diego, CA) or the East Coast (preferably near Raleigh, NC or Boston, MA). The role necessitates occasional travel between these locations to facilitate cross-site collaboration and meet business requirements.
The Associate Director of CMC and Technical Operations Program Management is tasked with:
Leading a global, cross-functional technical CMC team, coordinating with associated functions such as Quality and impacted CMO/CLOs to produce all necessary technical documentation for an approvable NDA Module 3 and to effectively implement technical and regulatory strategies.
Overseeing project management for all key CMC deliverables, including generating reports, coordinating team interactions, ensuring meetings are structured and purposeful, documenting clear decisions/actions, and communicating these to team members and relevant stakeholders while holding them accountable for their deliverable responsibilities.
Ensuring comprehensive program plans are in place, including managing cross-functional dependencies, particularly:
Facilitating the establishment and tracking of program objectives and priorities while monitoring progress against approved project plans (ensuring timely and budget-compliant delivery).
Coordinating the identification and mitigation of program issues and risks, ensuring robust risk mitigation plans are in place.
Creating well-rounded, scientifically sound scenarios that serve as decision proposals at all governance levels.
Managing the review process of technical documents (including protocols, reports, master and executed batch records, change controls, deviations, etc.).
Preparing for governance and executive management program presentations in close collaboration with the leadership team.
Managing the program budget and long-term projections, including budget planning and tracking, while evaluating project resource requirements: identifying resource gaps and working to address them.
Following up on invoices and verifying the accuracy of work execution against the budget commitments.
Performing other job-related tasks as needed.
