Position Overview

Beam is seeking an Associated Director / Director, Patient Supply who will provide leadership, planning, and execution of clinical supply activities to support the Beam Therapeutics in-vivo gene editing clinical program.  This key position will collaborate with internal and external stake holders in developing the clinical supply budgets, plans, and will manage time-sensitive activities to deliver clinical trial supplies to support patients.  This role will operationally deliver investigational medicinal product for complex studies, IRT and include packaging, developing label strategies and defining the logistics strategy for Beam’s clinical trials. This position will closely interface with Clinical Operations, Quality, CMC, Regulatory, CDMOs and CROs to ensure clinical/investigational material is available as required to achieve clinical trial strategy and program timelines.

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.

Qualifications:

• BS in Pharmacy or related science, advanced degree in pharmacy preferred.
• 12+ years of pharmaceutical experience with at least 7 years experience in clinical supplies managing complex projects. Direct experience with Cell and Gene Therapy clinical supply is highly preferred.
• Prior investigational drug product experience and prior GCP training is required. Recent industry experience with clinical supplies or clinical operations is preferred.
• 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.
• Prior Biopharmaceutical or pharmaceutical R&D experience preferred.
• 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.