CMC / Technical Operations Program Manager - Associate Director

Location Requirement:
This position may 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 requires periodic travel between both locations to support cross‑site collaboration and business needs. 

The CMC / Technical Operations Program Manager - Associate Director is responsible for:

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution.  

• Project manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans 

• Assure integrated program plans are in place including cross-functional interdependencies, in particular: 

• Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans (ensures we deliver on time and on budget) 

• Coordinates the identification and mitigation of program issues and risks, assures risk mitigation plans 

• Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels  

• Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)  

• Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team 

• Responsible for program budget and long-term projections – budget planning and tracking, and evaluates project resource requirements: highlights resource gaps and works to ensure they are addressed 

• Follow the invoices and confirm the corresponding work execution to the budget owner  

• Other job related tasks