Company Overview

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.

Position Overview

Beam is seeking an experienced Director, Filing Excellence Program Manager to provide project leadership for major global regulatory submissions, including Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and associated Health Authority review activities. Working closely with Regulatory Affairs and cross-functional leaders, this role will translate regulatory strategy into an integrated execution plan that aligns content development, data availability, submission readiness, and review-cycle activities.

This individual will drive the end-to-end submission operating model, establishing the critical path, governance, decision-making forums, risk management, and readiness processes required to deliver high-quality submissions on time. The Director will serve as a central point of integration across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations.

The ideal candidate is an experienced regulatory project leader who combines deep submission execution experience with strong cross-functional leadership, operational judgment, and the ability to create clarity and drive decisions in complex, fast-moving environments.

Responsibilities

Drive integrated submission planning and execution by establishing and leading the end-to-end submission plan and critical path, including content development, data availability, review and approval cycles, publishing, submission, and Health Authority review.
Translate regulatory strategy into an executable operating plan by partnering with Regulatory Affairs and functional leaders to define deliverables, ownership, milestones, decision points, dependencies, and readiness criteria across submission modules and workstreams.
Lead cross-functional submission readiness across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations, ensuring alignment of data, analyses, documents, and submission content.
Drive critical submission milestones, including readiness for pre-submission Health Authority interactions, content completion, cross-functional reviews and approvals, quality-control activities, publishing handoffs, and final submission readiness assessments.
Establish submission governance and decision-making forums, with clear decision rights, escalation pathways, risk management, and executive reporting that enable rapid issue resolution and informed leadership decisions.
Provide clear visibility to submission readiness through fit-for-purpose dashboards, milestone tracking, risk and decision logs, and executive reporting focused on critical-path status, emerging risks, resource constraints, and decisions required.
Lead rolling-submission planning and execution (when applicable) by defining module sequencing and associated content, data, review, approval, and publishing dependencies; identify timing risks and drive mitigation and recovery planning.
Lead Health Authority review-cycle execution, including cross-functional planning and rapid-response activities for information requests, labeling, inspection readiness, commitments, and other critical milestones through approval.