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 that includes a suite of gene editing and delivery technologies and is in the process of building 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 potential 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 a highly motivated, Director or Senior Director, clinical data management to oversee all data management deliverables from Beam clinical trials.  The ideal candidate will collaborate closely with the Beam study team and CRO data management to ensure timely, accurate, complete, high quality data deliverables. This position will manage data management contractors and require hands-on work on clinical studies as the first in-house data manager.

Responsibilities:

• Lead the Clinical Data Management (CDM) function, collaborating closely with cross-functional teams to oversee all data management deliverables and timelines for Beam clinical trials
• Oversee CRO data managers and manage data management contractors, providing guidance and oversight to ensure timely and high-quality execution of the CDM activities across all Beam clinical trials.
• Develop, implement and maintain CDM SOPs and working instructions, ensuring consistency, regulatory compliance and best practices across the department.
• Serve as the primary point of contact for data management, liaising with CROs, third-party data vendors, and internal stakeholders to ensure smooth communication and alignment.
• Lead data management activities during the study start-up and throughout the trial lifecycle, activities including but not limited to: CRF design, cross- functional CRF review, edit checks specification review and approval, database setup , user acceptance testing, CRF completion guidelines review and approval, CRO data management plan review and approval, external data transfer specifications and other essential documentations review and approval, vendor data reconciliation and SAE reconciliation oversight, data review and data cleaning oversight.
• Oversee CRO’s ongoing review and cleaning of clinical data, which including EDC data review, vendor data review and reconciliation, supporting study deliverables.
• Coordinate and facilitate internal cross-functional teams data review activities to ensure data quality and integrity, present data management activities progress, interim data cleaning metrics and final reports to internal teams and stakeholders, ensuring transparency and supporting data-driven decision-making.
• Manage the database lock process and ensure proper archiving of study data in compliance with regulatory requirements.
• Provide expertise on CDASH and CDISC data standards, collaborating with Statistical Programming to ensure accurate SDTM mapping.
• Lead GCP inspection readiness efforts, acting as the primary point of contact for data management during regulatory inspections and ensuring the department is prepared for audits.

Qualifications:

• Bachelor’s or master’s degree in a scientific or health-related field with 15+ years of experience; level will be commensurate with experience
• Minimum of 14 years of experience in clinical data management within the pharmaceutical or CRO, with experience in managing Phase I, II and III studies, from start-up through closure for multiple clinical studies
• At least 4 years of management experience with strong organizational, leadership and project management skills
• Extensive knowledge and experience in study start-up, study conduct and study closeout
• Proficiency with EDC systems including Oracle Inform and/or Medidata Rave, and expertise in CDASH/CDISC standards, GCP/ICH guidance, and relevant FDA regulations
• Experience developing reports using J-Review and/or other CDM reporting tools
• Prior experience with IND filings and NDA/BLA submission is highly desirable
• Highly organized, detail-oriented, and equipped with strong analytical and problem-solving skills
• Self-motivated, with the ability to work independently and collaborate effectively with colleagues and vendors.
• Excellent verbal and written communication skills are essential
• Proven ability to prioritize and manage timelines while adapting to shifting priorities within a fast-paced company environment
• Experience and knowledge of gene/cell therapy and/or rare disease are desirable
• Being able to come onsite on a regular basis is preferred