Clinical Science Principal (Remote)

Job Description

General Summary:

The Clinical Scientist Principal will 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 on design, execution, and monitoring of clinical trials, as well as data interpretation and communication. This role will also serve as a point of contact for investigators in day-to-day clinical study needs.

Key Duties and Responsibilities:

• Works 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.
• Conducts 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.
• Analyzes and synthesizes information to assess issues relating to protocol conduct and/or individual subject safety.
• Provides 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.
• Develops protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents with minimal direction from the Medical Lead.
• Collaborates with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations.
• Represents Vertex to outside personnel in the development of clinical protocols and study conduct
• Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
• Leads literature reviews as needed.
• Prepares scientific material for conference presentations or publications.

Knowledge and Skills:

• In-depth knowledge in analysis and interpretation of clinical data (safety and efficacy); proficient knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
• Ability to make independent, timely and appropriate decisions.
• Strong oral and written communication skills to explain difficult information 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.
• Flexibility 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.

Education and Experience:

• Bachelor's degree in the Life sciences
• Typically requires 6 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting, or the equivalent combination of education and experience.

#LI-Remote

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. 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