Job Description

The Clinical Scientist will work with the Medical Lead and provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring 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 investigators in day-to-day clinical study needs. This individual may also participate in selected projects in clinical development. This individual will report into Global Clinical Operation , 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 oversight by the Medical Lead to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, 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.
• Provide clinical 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.
• Interact 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 conduct
• Contribute 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.
• Support preparation of scientific material for conference presentations or publications.
• Collaborates with cross-functional groups at Vertex for assigned studies.
• Performs other duties as assigned related to clinical programs

MINIMUM QUALIFICATIONS:

• Life sciences degree with 4-6 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 innovatively
• Flexible 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.

PREFERRED QUALIFICATIONS:

• Advance degree in life sciences (e.g.; PharmD/PhD, Masters, Nursing, etc.) with clinical research experience in the pharmaceutical industry or healthcare setting.
• Experience working with clinical trial sites.
• Experience in all stages of drug development.
• Global clinical research experience.

Pay Range:

Disclosure Statement:

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