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Director, Filing Excellence Program Manager

Beam Therapeutics · Cambridge, MA · On-site

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About Beam Therapeutics

Backed by GV.

About the role

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. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • BS 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
More about this role

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.

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...

Read the full posting on Beam Therapeutics's site ↗

Program Management

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