Associate Director, Clinical Scientist (Hybrid)

Job DescriptionThe Associate Director Clinical Scientist will work as the key clinical interface working with the Medical Lead to provide scientific, clinical, and operational input to early and late stage clinical development programs (including Cystic Fibrosis, or Neurology), with an emphasis on program strategy activities. This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication. This role will also serve as a point of contact for CROs and investigator. This individual may also participate in selected projects in clinical development. This individual will report directly into the Sr. Director of Clinical Development Execution, and will interface directly with other functions (including Clinical Development, Clinical Dev Execution, Medical Writing, Biometrics, Patient Safety, Medical Affairs, Clinical Pharmacology and Biomarkers, and Regulatory Affairs) to support the development of novel therapeutics.KEY RESPONSIBILITIES:Work with cross-functional team with minimal oversight by the Medical Lead to conduct clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities.Support Medical Lead with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs. Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Lead. Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety. Assist in communicating a clear overview of trial results.Provide operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Lead.Lead interactions with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.Represent Vertex to outside personnel in the development of clinical protocols and study conductContribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.Prepare literature reviews as needed.Present and support preparation of scientific material for conference presentations or publications.Collaborates with cross-functional groups at Vertex for assigned programs as the clinical representative and liaison to the therapeutic area.Performs other duties as assigned related to clinical programsREQUIREMENTS:Life sciences degree with at least 5 years of clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting.Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.Ability to make independent, timely and appropriate decisions.Excellent oral and written communication skills and solid computer/analytical skills.Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.High level of organizational and project management skills.Ability to think creatively and innovativelyFlexible to accommodate changes in team and project needs.Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.LI-HYBRIDCompany InformationVertex 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.Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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 [Click Here to Email Your Resumé].

Created: 2025-11-15