Provides medical safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development) Responsible for the safety assessment activities of assigned products under the supervision of a Global Patient Safety (GPS) Disease area Safety Head Autonomously monitors the benefit risk profile of assigned products/portfol

In this key strategic role, the Director will be a critical leader within the Heme Global Commercial team supporting CASGEVY (exagamglogene autotemcel, or 'exa cel'). They will be accountable for driving the full Global potential of this first of its kind innovation across both indications. The role will have a strong focus on commercialization strategy of CASGEVY. The su

Ability to empower teams and individuals and hold them accountable Executive presence, strong business acumen, ability to navigate ambiguity and manage complexity Exhibits intellectual curiosity and integrity and has a strong passion for innovation Ability to think strategically and effectively assess, plan, and prepare recommendations Highly developed interpersonal skill

The Associate Director, Biomarker Operational Quality will provide biomarker quality leadership and oversight across GxPs related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. This leader will collaborate with business partners and GCP Operational Quality to drive quality outcomes and ope

The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post approval global regulatory CMC strategies for a marketed cell and gene therapy product. This role provides regulatory guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriatel

Through internal audits the Internal Audit Manager will identify risk areas, evaluate business process controls and complete test plans. Additionally, this role will provide recommendations to improve the effectiveness and efficiency of operations and business systems. This role will also participate in ensuring that the yearly internal control review is brought to fruiti

Provides comprehensive expertise and guidance in the Therapeutic Area and Vertex drugs Develops and maintains professional relationships with local Health Care Professionals, and with local Professional Societies and Patient Advocacy groups. Establishes relationships with Thought Leaders to expand research opportunities for Vertex and develops, at local level, advisory, c

The Manufacturing Operations Supervisor leads shift work in the manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily clinical GMP operations at the Leiden Center 1 (LC1) in Boston. Overseeing the daily work of shift personnel across multiple suites and responsible for daily operation and staff allocations for second shift

The Legal Senior Counsel provides solutions oriented legal advice and support to assigned business functions on a broad array of strategic and tactical matters within a highly regulated environment.The Legal Senior Counsel demonstrates a high degree of autonomy representing significant risk and complexity, working closely with senior company leaders. Key Duties and Respon

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, Du

Guidance & Patient Support (GPS) Insights is an industry leading patient support analytics and insights team established to deliver core reporting needs and apply predictive/prescriptive insights that can be applied to continuously enhance the GPS patient experience. The function is part of the GPS Patient Experience Team and it drives analyses that underpin this patient

The Analytical Science and Technology Scientist will work collaboratively with a diverse group of stakeholders in support of Vertex's commercial manufacturing by managing outsourced QC testing, conducting analytical investigations, authoring protocols, reviewing regulatory submissions, and managing the coordination of several analytical and Manufacturing Science and Techn

The Director, Analytical Development is a key leadership role within the Cell and Gene Therapy Analytical Development function and will be responsible for establishing and leading the company's analytical testing strategy (manual and automated), operations, and implementing testing automation capabilities. This role will work collaboratively with the Manufacturing, Proces

Vertex currently operates at the forefront of rare disease scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) and Sickle Cell Disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious

Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple