Associate Director, Clinical Scientist (Remote)

Job Description

General Summary:

The Clinical Scientist Associate Director will work as the key clinical interface to provide scientific, clinical, and operational input to early and late stage clinical development programs, 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 may also participate in selected projects in clinical development.

Key Duties and Responsibilities:

• Works with cross-functional team with minimal oversight by the Medical Lead only in the most complex situations 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.
• Develops/prepares 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 complex information to assess issues relating to protocol conduct and/or individual subject safety.
• Communicates a clear overview of trial results.
• Collaborates with Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Leads the development of protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents under the direction of the Medical Lead.
• Leads 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.
• Represents Vertex to outside personnel in the development of clinical protocols and study conduct
• Leads the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors.
• Develops complex literature reviews as needed.
• Prepares and presents scientific material for conference presentations or publications.

Knowledge and Skills:

• Advanced experience in analysis and interpretation of clinical data (safety and efficacy); strong 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.
• 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
• Typically requires 8 years of experience in clinical or pre-clinical research in the pharmaceutical industry or healthcare setting in Phase 1-4, or the equivalent combination of education and experience.

Pay Range 156,000 - 234,000 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.

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 .