Job Description General Summary: We are seeking a highly motivated professional to join our Biomarker Department to work in a dynamic and cross-functional environment spanning early to late-stage clinical development. The Biomarker Operations Project Manager will focus on Imaging Operations and oversight of key biomarker vendors not limited to imaging. The successful candidate will act as an important contributor to clinical development of novel therapies to treat rare diseases. In this position you will provide operational excellence, project management, and vendor oversight expertise for the execution of imaging assessments on Vertex clinical trials, execution of pre-trial imaging projects that guide clinical trial planning, and imaging biomarker portfolio management and tracking. Additionally, you will own project management support, inclusive of budgets related to key biomarker vendors and projects. You will need to ensure clear communication and maintenance of project timelines, conduct operational risk identification and propose mitigations, and provide budget forecast updates. This role will closely collaborate with clinical imaging leads, biomarker or diagnostic leads, biomarker operations team, clinical trial operations, quality assurance, data management, finance, and imaging CROs and biomarker vendors. Your role will ensure high quality and timely delivery of results and maintain close contact with Biomarker program leadership to communicate activities. Key Duties and Responsibilities: * Work with colleagues in the Biomarkers Department for the implementation of imaging biomarkers and other key biomarkers (not limited to imaging) in pre-clinical and clinical studies to meet program goals * Responsible for project management support with CROs, consultants and vendors in collaboration with imaging or biomarker leads. This may include facilitating vendor selection activities, scope of work assessment and contract management, development and adherence to timelines, and oversight of deliverables to ensure clinical trial readiness * Ensure contracts are executed expeditiously through coordination with vendors and across internal functions (finance, outsourcing) * Assist with oversight of and maintaining budget forecast for biomarker projects while ensuring invoicing is clearly tied to contract timelines * Maintain trial and project portfolio and track activities for assigned programs including preparation of Gantt charts and presentations for senior management * Attend trial-specific, vendor, and cross-functional team meetings to support operational oversight and risk identification, as needed * Accelerate resolution of imaging related questions originating from clinical trial sites, CROs, clinical operations, and ethics committees with cross-functional team input * Coordinate with Quality Assurance on issue resolution and documentation * Facilitate cross-functional document reviews and file expected documents in sponsor Trial Master File (TMF) * Review clinical trial study documents for biomarker related content and update as applicable * Lead and participate in process or SOP improvements, as applicable Knowledge and Skills: * Knowledge of Good Clinical Practices, clinical study design and implementation is required * Excellent written and oral communication * High attention to detail and ability to prioritize and plan * Excellent project management and organizational skills * Skills with project timeline management software is a plus (e.g. Microsoft Project, Smartsheet, Thinkcell, or other) * Advanced skills in Microsoft Excel, PowerPoint, and Word * Ability to oversee operational activities across multiple studies and programs with little to no oversight. * Knowledge and understanding of general scientific principles as applied to biomarker research, development, and implementation Education and Experience: * Bachelor's degree in biology or related field with a minimum of 4+ of experience in the pharmaceutical industry. * The equivalent combination of education and experience will also be considered. * Strong awareness of clinical operations, vendor management, quality, and finance disciplines * Demonstrated ability to collaborate well with a diverse group of scientists, vendor labs, clinical operations, and a variety of internal/external stakeholders * Experience working with CROs on clinical trials Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com