Director, Filing Excellence Program Manager

The posting, as Beam Therapeutics wrote it

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

[…]
in a scientific, technical, or related discipline required; advanced degree preferred.

• Typically 12 + years of experience with 10+ years of biotechnology or pharmaceutical industry experience, including 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 end-to-end path 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.
• Proven ability to influence across functions and organizational levels, drive decisions without direct authority, and maintain execution discipline in complex, fast-paced environments.
• Experience managing Health Authority information requests, inspection-readiness activities, labeling, or other post-submission review activities strongly preferred.
• Experience with cell or gene therapy programs and accelerated development or approval pathways preferred.
• Proficiency with Smartsheet or comparable project-management, collaboration, and portfolio-planning tools.
• Strong facilitation, problem-solving, communication, and leadership skills, with the ability to translate complex information into clear priorities, actions, and decisions.
• Candidates must live locally and be able to work from Beam's Cambridge location 1 to 3 days per week as needed.

The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.

Beam Pay Range
$210,000 — $260,000 USD