The Director, GCP Compliance is responsible for the escalation and management and compliance activities in support Quality Issues Management and other activities within RDQA. This role will act as a lead for GCP related events and escalation of these events. This individual will work closely with Quality Leads, Study team members, and other pillars in the Quality organiza

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

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

The successful candidate will possess a deep knowledge of process chemistry skills for the development of synthetic routes, with early and late phase development experience and delivering drug substance under tight timelines. They will have a strong interest in laboratory work and will be key to driving the development of safe and scalable chemistry. They will spearhead t

The Senior Director Publications is responsible for contributing to the co creation and strategic development of medical and scientific publications included in a global disease publication plan. This role will provide leadership and expertise in publications creation and execution. This position has a hybrid schedule which allows for 2 days per week working remotely and

The Vendor Quality Management Director provides technical and strategic leadership for vendor quality, vendor quality processes, and associated governance for the cell and gene therapy business unit. This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk based compliance. This is a hybrid role located in our Seaport offices. Key Du

Independently authors routine and complex clinical and regulatory documents Provides strategic input into program level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Scienc

The Associate Director (AD), Commercial Supply Chain Risk Management will aid in formulating and executing, optimizing, stabilizing, and scaling of the new Risk Management framework and overall Risk Management strategy to ensure it keeps pace with the growth of the company and Commercial Manufacturing and Supply Chain (CMSC). The Associate director will also play a role i

The Senior Principal Research Scientist is self reliant with a proven record of accomplishments, independently identifying and solving complex problems using sophisticated scientific methods and analytical thought, across a number of critical and diverse projects. The Senior Principal Research Scientist encourages use of diverse experimental approaches within their area o

Lead the delivery of therapeutic area specific analytical insights in response to market access landscape, issues and trends. Generate insights and develop KPIs as part of US market access readiness launch activities, including evaluating in market analogs pricing & contracting environment, payer/PBM landscape, clinic/hospital economics, employer groups, value based agree

Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manu

Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manu

Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs) Develops and maintains expertise on the product's clinical attributes and patient unmet need and educates healthcare professionals on product use in appropria

The Associate Director, Manufacturing Operations This role enables the commercial manufacturing of combination devices to support our ongoing programs. They will support the implementation of commercially capable processes for manufacturing. S/he will understand device manufacturing, including working with device development and clinical manufacturing to enable commercial

The Technical Accounting and SEC Reporting Associate Director is primarily responsible for researching and documenting accounting positions and analyses for a variety of complex areas, as well as proactively monitoring and performing impact analyses with respect to new accounting standards and other regulatory developments. This position is based in our Boston, MA office,