Director, Filing Excellence Program Manager

Beam Therapeutics•Cambridge, MA

2d•$210,000 - $260,000•Hybrid

About The Position

Beam Therapeutics is seeking an experienced Director, Filing Excellence Program Manager to lead major global regulatory submissions, including Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and associated Health Authority review activities. The role partners closely with Regulatory Affairs and cross-functional leaders to translate regulatory strategy into an integrated execution plan aligned across content development, data availability, submission readiness, and review-cycle activities. The Director will drive the end-to-end submission operating model, establishing the critical path, governance, decision-making forums, risk management, and readiness processes needed to deliver high-quality submissions on time. The role serves as a central point of integration across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations. The position is based around Beam’s Cambridge location, with local candidates expected to work there one to three days per week as needed.

Requirements

Bachelor of Science degree in a scientific, technical, or related discipline.
Typically 12 or more years of experience, including 10 or more years in the biotechnology or pharmaceutical industry, with significant leadership of complex cross-functional programs or projects.
Direct, hands-on experience leading the planning and execution of at least one major marketing application, preferably a BLA, through submission and Health Authority review.
Strong understanding of eCTD structure, submission content dependencies, regulatory operations, and the process from content development through review, approval, publishing, and submission.
Demonstrated ability to lead integrated submission planning, governance, readiness assessments, risk management, and executive-level reporting.
Ability to influence across functions and organizational levels, drive decisions without direct authority, and maintain execution discipline in complex, fast-paced environments.
Proficiency with Smartsheet or comparable project-management, collaboration, and portfolio-planning tools.
Strong facilitation, problem-solving, communication, and leadership skills, including the ability to translate complex information into clear priorities, actions, and decisions.
Must live locally and be able to work from Beam’s Cambridge location one to three days per week as needed.

Nice To Haves

Advanced degree.
Experience managing Health Authority information requests, inspection-readiness activities, labeling, or other post-submission review activities.
Experience with cell or gene therapy programs and accelerated development or approval pathways.

Responsibilities

Establish and lead the end-to-end submission plan and critical path, including content development, data availability, review and approval cycles, publishing, submission, and Health Authority review.
Partner with Regulatory Affairs and functional leaders to translate regulatory strategy into an executable operating plan with defined deliverables, owners, milestones, decision points, dependencies, and readiness criteria.
Lead cross-functional submission readiness across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations.
Drive critical submission milestones, including pre-submission Health Authority interaction readiness, content completion, cross-functional reviews and approvals, quality-control activities, publishing handoffs, and final submission readiness assessments.
Establish submission governance and decision-making forums, including decision rights, escalation pathways, risk management, and executive reporting.
Provide visibility into submission readiness using dashboards, milestone tracking, risk and decision logs, and executive reporting on critical-path status, risks, resource constraints, and decisions required.
Lead rolling-submission planning and execution when applicable, defining module sequencing and dependencies across content, data, review, approval, and publishing; identify timing risks and drive mitigation and recovery plans.
Lead Health Authority review-cycle execution, including cross-functional planning and rapid-response activities for information requests, labeling, inspection readiness, commitments, and other milestones through approval.
For FDA submissions, integrate USPI, PLI, BIMO inspection-readiness, and launch-readiness activities into the submission and review-cycle plan, ensuring clear ownership, dependencies, decision points, and cross-functional alignment through approval and launch.
Drive resource and capacity planning for submission-critical workstreams with functional leaders, establishing priorities, resolving competing demands, and implementing recovery plans as needed.
Build scalable submission-management capabilities by establishing standardized plans, dashboards, workflows, and reporting practices using Smartsheet and other project-management tools.