Toxicology Senior Principal Research Scientist

Job Description

General Summary:

The Senior Principal Research Scientist is self-reliant with a proven record of accomplishments, both leading others, and independently identifying and solving complex problems using sophisticated scientific methods and analytical thought, across a number of critical and diverse projects. As a member of the Preclinical Safety Assessment (PSA) organization, this person will be responsible for the development of non-clinical safety, scientific and regulatory strategies, provide guidance, mentorship of PSA and VCGT staff, and preparation of high-quality reports and presentations.

Key Duties and Responsibilities:

• Designs and performs sophisticated and complex, technically challenging experiments that impact the achievement of department and project goals
• PSA representative on Project and Development teams from compound selection through loss of exclusivity
• Responsible for development and alignment of nonclinical strategies to support clinical development of assigned projects
• Responsible for the planning, design, oversight, and communication of results from toxicology studies
• Responsible for lead authorship of internal and external regulatory documents/dossiers (IB, CTX, IND, NDA, briefing books, regulatory queries, expert report etc.)
• Address and resolve toxicologic issues in drug development programs, and assess the relevance of any toxicologic findings to human safety
• Conduct risk assessments for impurities, degradation products, novel excipients, and metabolites
• Communicate critical and significant project information to various bodies including PSA leadership, project teams and other Vertex leadership forums
• Build strong scientific collaborations with external groups within the academic & industrial sectors with the intent of enhancing Vertex's PSA capabilities

Knowledge and Skills:

• Subject matter expertise in toxicology and the design and interpretation of in vitro and in vivo studies in common preclinical species
• Proficient knowledge of general toxicology, the design and interpretation of studies to support regulatory submissions
• Experience in the development of biologics and small molecules
• Excellent written, verbal communications and ability to persuade others presenting technical/scientific concepts to diverse audiences
• Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities

Education and Experience:

• Bachelor's, Master's, or PhD in Toxicology, Pharmacology or a related life sciences
• PhD and 6-8+ years, or Master's and 9+ years, or Bachelor's and 11+ year, or the equivalent combination of education and experience

Flex Designation:

Flex Eligibility Status:

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