Vertex has established a new research site in Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat and even cure several of the diseases Vertex is focused on, including sickle cell disease, D

Provides leadership and oversight of DASH/Disease area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre FIH activities, key benefit risk assessment, and providing strategy for DSTs to meet goals and objectives. Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in acco

Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre FIH activities, benefit risk assessment, and strategy for DSTs. Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices. Collaborates with Clinical Leaders to develop and implement appropriate Risk Management p

The GMP Quality Operations Director serves as a Quality leader in the areas of process validation, and equipment validation in oral solid dosage form. The Director is also responsible for managing multiple department activities with a high degree of independence while providing oversight of the development, implementation, and maintenance of relevant quality initiatives i

The Training Associate Director is responsible for supporting the oversight of all Training related activities within the Global Regulatory Affairs organization. This role will work to create, curate, and deliver top notch learning experiences including both technical and professional development for the team. The Training Associate Director will report directly to the Se

The Director, Modeling & Simulations (M&S) Pharmacometrics will be responsible forindependently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross functional colleagues within the R&D organization. In this role, it is expected that the incumbent will represent M&S with cross functional drug developmen

Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go to market/launch, and lifecycle decisions for future launches. Executed in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing. Develop strong partners

Our department is a highly collaborative collection of groups consisting of biology, engineering, modeling and simulation, and prototyping, centered around developing cutting edge transformative cell and gene delivery platforms. In this position the intern will support routine analytical testing and material characterization, in addition to assisting with fixture design,

Build and manage a manufacturing engineering team for DSDP cells and combination products Act as primary technical and engineering manufacturing lead design reviews, documentation with focus on designing for manufacturability. Implement, propose and drive the implementation of Drug Product Device and manufacturing engineering controls by integrating Vertex QMS, production

The Process Engineering Senior Manager role delivers on complex manufacturing activities in a technical area and is responsible for ensuring effective relationships with all stakeholders. T he role is responsible for successful process validation and commercial manufacturing, drives resolution of complex manufacturing issues. The successful candidate will champion high im

The Package Engineering Senior Manager is an emerging professional within the department. This role delivers on complex outsourced manufacturing activities in Packaging and is responsible for ensuring positive and effective relationships with all stakeholders. This role will focus primarily on commercializing cell & gene therapy products and preparing pipeline products fo

The Process Engineering Manager delivers reliably and responsibly on independent activities and is responsible for execution and oversight of internal or external manufacturing operations in a technical area. The incumbent is a key participant on internal and external cross functional teams within their technical area for one or more supplier(s). The role assists in maint

Provides comprehensive expertise and guidance in designated therapeutic area(s) and Vertex medicines Leads a team of physicians and scientists to create and execute appropriate medical affairs plans and tactics supporting designated therapeutic area(s) and Vertex medicines Develops and maintains professional relationships with local Health Care Professionals, and with loc

The Associate Director, Information Systems Management entails providing risk based oversight to Computerized Systems Life Cycle activities across broad spectrum of technologies ranging from Automated Systems to Enterprise Wide systems and Software as a Service (SaaS) solutions. This role ensures risk based, overall integrity of electronic data across all stages of data l

Develop engagement strategy and account plans to ensure success with target IDNs, GPOs and GPO aggregate accounts Engage with IDN, GPO and GPO aggregate account leadership, formulary decision makers, and population health stakeholders to ensure timely access and contracting, support product uptake, drive systemic change, and pursue creative partnerships, as appropriate Co