About the job
Location Requirement:
This position can be based on either the U.S. West Coast (ideally near San Diego, CA) or the East Coast (ideally near Raleigh, NC or Boston, MA). The role necessitates periodic travel between both locations to facilitate cross-site collaboration and fulfill business requirements.
The Associate Director for CMC / Technical Operations Program Management plays a crucial role in:
Leading an international, cross-functional technical CMC team, collaborating closely with associated functions such as Quality and impacted CMO/CLOs to ensure the delivery of all necessary technical documentation supporting an approvable NDA Module 3 and translating technical and regulatory strategies into actionable execution.
Project managing all key CMC deliverables, including the underlying reports, coordinating team interactions to ensure meetings are structured and purposeful, documenting clear decisions and actions, and communicating them effectively to team members and relevant stakeholders while holding team members accountable for the functional delivery of plans.
Assuring the presence of integrated program plans that encompass cross-functional interdependencies.
Facilitating the establishment and tracking of program objectives and priorities while monitoring progress against approved project plans to ensure timely and budget-compliant delivery.
Coordinating the identification and mitigation of program issues and risks, ensuring comprehensive risk mitigation plans are in place.
Building holistic, scientifically sound, and relevant scenarios as decision proposals for all governance levels.
Coordinating the review process of technical documents, including protocols, reports, master and executed batch records, change controls, and deviations.
Preparing governance and executive management program presentations in close collaboration with the leadership team.
Managing program budgets and long-term projections, including planning and tracking, evaluating project resource requirements, highlighting resource gaps, and ensuring they are addressed.
Overseeing invoice follow-ups and confirming work execution aligns with the budget owner's expectations.
Performing other job-related tasks as necessary.