Jobs at Beam Therapeutics

The Associate Director/Director of Toxicology leads nonclinical safety assessments, oversees study execution, and supports regulatory filings for gene therapy programs.

The Associate Director oversees quality assurance for Cell and Gene Therapy programs, ensuring compliance with regulations and supporting product lifecycle management.

Lead pharmacovigilance activities for Beam products, providing scientific and operational PV support across clinical development and lifecycle. Oversee safety monitoring, ICSR assessment, signal detection, aggregate reporting, vendor management, inspection readiness, SOP development, cross-functional safety governance, database migrations, and PV training. Act as PV SME and contribute to PV strategy, quality, and compliance.

Lead and manage statistical programming for clinical studies, oversee CROs, develop and validate SDTM/ADaM datasets and TFLs, support regulatory submissions (NDA/BLA), build programming infrastructure, and mentor programming staff while collaborating with cross-functional clinical teams.

Lead study-level biostatistics for clinical trials: design, SAPs, TLFs, CRF and randomization review; oversee CRO biometrics and programmers; perform analyses, support regulatory submissions, and collaborate cross-functionally.

Lead and execute analytical method qualifications, validations, and transfers to support cGMP manufacturing. Perform routine GMP testing (in-process, release, stability), document results in LIMS/LES, support investigations, change controls, instrument maintenance, and continuous improvements while collaborating with Quality, Manufacturing, MS&T, and Analytical Development.

Lead onboarding and quality integration for commercial treatment centers, managing qualification, audits, agreements, risk mitigation, CAPA tracking, and performance metrics. Ensure compliance with FDA 21 CFR and GxP areas, prepare centers for inspections, drive continuous improvement of SOPs, training, and quality systems, and coordinate cross-functional stakeholders to support scalable commercial operations.

The role leads global supply chain planning, ensuring uninterrupted supply of products, inventory management, and effective collaboration with cross-functional teams.

The Director, HCP Marketing leads healthcare professional engagement strategies, develops marketing content, and manages agency relationships for effective product launch and adoption.

Lead GMP-quality oversight for external CDMOs and internal Cambridge QC, establish KPI/metrics, manage audits/investigations, ensure cGMP/GxP compliance, approve release documentation, provide technical product quality decisions, and drive continuous improvement of quality systems across clinical and commercial manufacturing.

Provide strategic and operational leadership for GCP inspection readiness and program quality oversight. Lead inspection risk assessments, mock inspections, remediation, and support health authority inspections. Serve as Clinical QA lead for studies, review clinical and regulatory documents, develop risk-based audit plans, oversee CROs and TMF quality, lead investigations and CAPAs, coach cross-functional teams on GCP R3, and contribute to QMS and SOP development.

The Vice President will lead the global HEOR strategy for sickle cell programs, develop evidence-generation plans, manage stakeholder relationships, and ensure alignment with regulatory standards.

Support GMP production and lead operations in a Cell Therapy environment, manage training, and collaborate cross-functionally.

Lead market insights, forecasting, and competitive intelligence for Beam’s portfolio. Build research capability, manage external vendors, develop market-sizing and demand models, support early pipeline analyses, and translate findings into strategic recommendations for cross-functional stakeholders.

Lead commercial engagement with Authorized Treatment Centers, driving site onboarding, operational readiness, and sustained therapy utilization. Develop strategic account plans, build executive relationships, coordinate cross-functional field pods, analyze utilization and referral trends, and represent the company at conferences to meet demand and activation targets.

Lead the QC CMC strategy for ex vivo cell therapy, defining analytical readiness, technical transfer, and lifecycle management of gene therapy products. Collaborate across functions to support regulatory submissions and ensure operational resilience.

The Vice President, Compliance oversees the Corporate Compliance Program, ensuring regulatory adherence, managing clinical supplies, and fostering a culture of accountability.

Lead state government affairs strategy to influence legislators, governors, and state Medicaid officials; build state-level networks; coordinate lobbying and advocacy; advise on federal/state policy risks and opportunities; collaborate with market access, regulatory, and patient advocacy teams; travel as needed.

Support monthly close, prepare journal entries and reconciliations, assist with internal/external financial statements, support audits and SOX reviews, contribute to system implementations and ad hoc financial analyses.

The Senior Director will lead global logistics, warehousing, and trade compliance strategy and operations to ensure compliance and support for clinical and commercial programs.