Associate Director, Viral Vector CMC Program Management

This is what you will do:

Associate Director, CMC Program Management is the key program/project and operational excellence leader for the CMC Program Management group for all early and late stage viral vector development assets. He/she provides global project & program management support to the CMC Teams within the Viral Vector Product Development group of Product Development and Clinical Supply (PDCS).  He/she is responsible for management and delivery of the integrated program timeline, including incorporating deliverables across functions, SMEs, and indications. This role will help to drive industry-leading PM best-practices across CMC teams/stakeholders. Viral Vector CMC Program Management is specifically responsible for program timelines as it relates to PDCS and other critical business partners (RA-CMC, QA, Operations, et al) as well as reporting, risk and budget management, scheduling, facilitating meetings and taking minutes, action items/follow-ups, and other PM-related duties.   

You will be responsible for:

• Drives development of the viral vector program CMC goals that enable on-time filings and delivery of clinical supply for all phases of development.  Monitors and reports on progress of the program goals.

• Leads generation, alignment, and continual monitoring of an integrated CMC program plan across functional lines involved in the development and delivery of supply.

• Leads cross-functional business integration plans and provides guidance on standardized tools/templates    

• Prepares and manages governance interactions in partnership with the CMC Lead.

• Provides key updates on program risks, progress and mitigation plans to management as needed.

• Responsible for program/project level budgeting and resource management 

• Provide robust program management tools, templates, 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, financial staging opportunities, and scenario planning

• Leads operational project management for CMC alliance or co-development programs, including contributing roles on alliance sub-committees and steering committees.  

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

• 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.

You will need to have:

• PhD in biochemistry, biological science, or chemical engineering or related fields with 4+ years of relevant experience, or BS/MS with 8+years of relevant experience in biopharmaceutical organization with expertise in drug substance/drug product development and/or tech transfer

• 4+ years of experience managing and leading multiple complex projects/programs within the biopharmaceutical industry, preferably as a CMC team leader.

• Must be able to create a highly collaborative and inclusive environment necessary for the cross-functional CMC teams to be effective.

• Strong 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.

• Viral-vector specific CMC challenges relating to raw material procurement and release, analytical testing, process development and manufacturing

• 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 record of achievement and delivery of team goals.

We would prefer for you to have:

• Knowledge of clinical and commercial manufacturing and distribution issues that impact project/product strategy and planning desirable. 

• Preference PM experience from candidate selection to thru approval

• Knowledge in planning for program advancement to process validation and commercial launch, with experience supporting teams through BLA approvals

• Regulatory submission authorship and/or review of relevant CMC sections for both US and ex-US dossiers

In-person statement for 4 days in the office:
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.