Beam Therapeutics · 9 hours ago
Vice President, Compliance
Cambridge, MA
Full-time
Onsite
Director/Executive
$310K/yr - $400K/yr
10+ years expBeam Therapeutics is a biotechnology company focused on precision genetic medicines. The Vice President, Compliance is responsible for designing and implementing the Corporate Compliance Program, ensuring the organization operates with integrity and in compliance with laws and regulations while fostering a culture of ethical conduct.
BiotechnologyGeneticsMedicalTherapeutics
Responsibilities
Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives, works with Clinical Operations and CMC to ensure timing of clinical trial investigational material needs are met
Work with cross function team Beam Team members (eg. Clinical Operations, QA and Regulatory) to create packaging strategies and label text for multiple countries/regions and provide support for regulatory filings as required
Provide technical expertise for the development of clinical study protocols and pharmacy manuals and will be required to develop dose preparation and administration strategies for complex gene editing products in early phases of development
Directly oversee and drive contract manufacturing packaging, labeling, national and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials
Responsible for IRT requirements, user acceptance testing, and management
Outline clinical supply risks and propose mitigation plans. Independently execute the mitigation plans
Participate in business review meetings with third party drug supply vendors, as needed
Establish SOPs, protocols, and procedures for clinical trial material packaging, labeling and distribution to ensure compliance with cGxP requirements
Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution
Compile and report out execution operational metrics for the cross functional teams
Author pharmacy manual in conjunction with relevant cross functional leads
Develop drug supply training materials for investigational sites
Manage Quality Systems required documentation, including Deviations, Investigations, CAPA's, Change Controls, Label and Product Specifications, and others as required
Subject matter expert for clinical trial supply during regulatory inspections
Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency. Ensure timely follow-up to all commitments in a project plan
Prepare supply and cost forecasts as required. Develop and manage clinical supply budget
Qualification
Required
BS in Pharmacy or related science
10+ years of pharmaceutical experience with at least 7 years experience in clinical supplies managing complex projects
Prior investigational drug product experience and prior GCP training is required
Demonstrated ability to work independently and with cross-functional teams, including Clinical Operations, CMC, Regulatory, Quality, and Finance
Demonstrated experience in managing third party contract clinical supply vendors
Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, and clinical trial designs for complex programs
Prior Cold Chain packaging, labeling, distribution experience required
IRT design and management experience required
Clinical Supplies Planning and Forecasting experience required
Independent, self-driven, creative and capable problem-solver with solid communication skills
Experience in establishing and maintaining positive and collaborative relationships with key internal and external stakeholders
Working knowledge of ICH/GxP guidelines, FDA, MHRA, EMA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
Good organizational, communication and presentation skills, effective project and time management skills and the ability to work well under pressure
Preferred
Recent industry experience with clinical supplies or clinical operations is preferred
Prior Biopharmaceutical or pharmaceutical R&D experience preferred
Advanced Degree in Pharmacy
Cell and Gene Therapy clinical supply experience
Direct Clinical Research Experience
Company
Beam Therapeutics
Beam Therapeutics is a biotechnology company developing precision genetic medicines through the use of base editing technology.
501-1000 employees
H1B Sponsorship
Beam Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (9)
2023 (12)
2022 (9)
2021 (7)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.19B2025-03-10Post Ipo Equity· $500M
2021-01-19Post Ipo Equity· $260M
2020-02-11Post Ipo Equity· $207M
Leadership Team
John Evans
CEO
Christine Bellon
Chief Legal Officer
Recent News
2026-01-23
2026-01-13
Company data provided by crunchbase