Program Manager, CMC Program(contract)

Job Location: Remote based; Can live anywhere in the U.S.

Position Summary

Program manager, CMC Program Management is the key program/project and operational excellence leader for the Global CMC Program and Operations Management group for all early and late stage development assets. He/she provides global program management support to the CMC Sub-team, driving industry-leading PM best-practices to align cross-functional stakeholders. He/she is responsible for management and delivery of the integrated program timeline, including incorporating deliverables across functions, SMEs and indications. This role is the key program management support to the Program Execution Team (PSET) and CMC Sub-team. The CMC Program Management organization is specifically responsible for program timelines as it relates to CMC functions, as well as project Gantt charts and reporting, meeting planning, integration support for BD, Program Execution Team meetings, scheduling and minutes, action items/follow-ups, and other PM-related duties.   

Principal Responsibilities
 
Program Management

• Drives development of the program execution team goals that enable the delivery of clinical supply for all phases of development.  Monitors and reports on progress of the program goals.
• Leads generation and alignment of a program specific Execution Plan across functional lines involved in the development and delivery of supply.
• Drives end to end program execution down to the task level to ensure alignment of CMC and cross functional related activities.
• Leads cross-functional business integration plans and systems while delivering program execution.
• Drives the task execution across multiple stakeholders to ensure program timelines are optimized and achieved.
• Lead the execution team on tactical program deliverables against the strategy developed by CMC Sub-team.
• Prepares and manages governance interactions in partnership with the CMC Sub-team lead.

 Operational Execution and Delivery
 

• Provide robust program management tools and practices to ensure delivery of supply and major market authorization filing via cross functional alignment and proactive problem solving.
• Drives execution of the program to achieve delivery and performance goals/objectives without compromising project deliverables or relationships. 
• Utilizes project management skills to drive projects to key decision points and milestones.  Proactive management of the critical path, operational feasibility of strategic plans, and active program risk management (risk registers, etc.), and alignment of operational execution.
• Monitors and manages progress against the program schedule including acceleration and staging opportunities.
• Leads operational project management for CMC on all alliance co-development programs, including contributing roles on alliance sub-committees and steering committees.  

  Risk Analysis and Management

• Partners with the team to identify contingency and risk mitigation strategies for project/program level plans

 Information & Communication Management
 

• Responsible for development and management of the communication plan for the program, including stakeholder management. 
• Defines and aligns program messages and major communications (internal and external) with the CMC lead and CMC team. Responsible for ensuring effective, accurate and timely communication of program information in order to facilitate development of options and team recommendations to governance.

 Qualifications

• 4-10 years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC PM or drug development PM.
  • Preference PM experience from candidate selection to FIH
  • Preference technical PM experience with combination product/audit remediation
• Must be able to create a highly collaborative and inclusive environment necessary for the cross-functional CMC teams to be effective.
• Strong track record in executing effective program management skills in cross-functional matrix organizations. 
• Excellent knowledge of program and project management discipline and its application to drug development to deliver time, cost, quality, and risk management to teams.
• Demonstrated success in creating and managing complex program plans, including experience with global teams, budgetary management, resource planning, and risk management.
• Demonstrated ability to effectively implement the tools and techniques of the program and project management discipline, such as the development and management of multi-disciplinary program level integrated plans, critical path management, project risk management, decision analysis and meeting management.
• Proven track record of achievement and delivery of team goals.
• Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning desirable.
   

Education

• Bachelors’ degree in business or scientific discipline required