Vertex Pharmaceuticals Incorporated
Toxicology Senior Research Fellow
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Job Description
General Summary:
The Toxicology Senior Research Fellow 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.
Overview Position focused on development of non-clinical safety strategies, leadership of PSA activities, and communication of study plans and results to cross-functional teams and external stakeholders.
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
Develops and aligns nonclinical strategies to support clinical development of assigned projects
Plans, designs, oversees, and communicates results from toxicology studies
Lead author of internal and external regulatory documents/dossiers (IB, CTX, IND, NDA, briefing books, regulatory queries, expert report, etc.)
Addresses and resolves toxicologic issues in drug development programs and assesses relevance to human safety
Conducts risk assessments for impurities, degradation products, novel excipients, and metabolites
Communicates critical project information to PSA leadership, project teams, and Vertex leadership forums
Prepares high quality reports and presentations to clearly communicate study plans and results
Keeps up to date with current literature and emerging industry trends in pharmaceutical toxicology and therapeutics; drives own professional development
Builds strong scientific collaborations with external groups to enhance 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, and study design/interpretation to support regulatory submissions
Experience in the development of biologics and small molecules
Excellent written and verbal communication; ability to persuade diverse audiences
Strong problem-solving skills; highly organized; able to thrive and lead in a dynamic environment
Education and Experience
Bachelor's, Master's, or PhD in Toxicology, Pharmacology or a related life sciences
Bachelor's degree and 20 years' experience or
Master's degree and 15 years' experience or
PhD and 11 years' experience
Pay Range:
$229,600 - $344,400
Disclosure Statement:
The range provided is based on 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 factors including skills, competencies, experience, and other job-related factors permitted by law.
Vertex offers Total Rewards including benefits to meet employees wherever they are in their career, financial, family and wellbeing journey, with resources to support growth and aspirations. Benefits include medical, dental and vision coverage, paid time off, educational assistance programs, student loan repayment, commuting subsidy, charitable donation matching, 401(k), and more.
Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
Hybrid : work remotely up to two days per week;
On-Site : work five days per week on-site with ad hoc flexibility.
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 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.
Application Assistance Applicants needing accommodation in connection with the hiring process or to perform essential functions should contact Talent Acquisition at
ApplicationAssistance@vrtx.com .
#J-18808-Ljbffr
The Toxicology Senior Research Fellow 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.
Overview Position focused on development of non-clinical safety strategies, leadership of PSA activities, and communication of study plans and results to cross-functional teams and external stakeholders.
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
Develops and aligns nonclinical strategies to support clinical development of assigned projects
Plans, designs, oversees, and communicates results from toxicology studies
Lead author of internal and external regulatory documents/dossiers (IB, CTX, IND, NDA, briefing books, regulatory queries, expert report, etc.)
Addresses and resolves toxicologic issues in drug development programs and assesses relevance to human safety
Conducts risk assessments for impurities, degradation products, novel excipients, and metabolites
Communicates critical project information to PSA leadership, project teams, and Vertex leadership forums
Prepares high quality reports and presentations to clearly communicate study plans and results
Keeps up to date with current literature and emerging industry trends in pharmaceutical toxicology and therapeutics; drives own professional development
Builds strong scientific collaborations with external groups to enhance 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, and study design/interpretation to support regulatory submissions
Experience in the development of biologics and small molecules
Excellent written and verbal communication; ability to persuade diverse audiences
Strong problem-solving skills; highly organized; able to thrive and lead in a dynamic environment
Education and Experience
Bachelor's, Master's, or PhD in Toxicology, Pharmacology or a related life sciences
Bachelor's degree and 20 years' experience or
Master's degree and 15 years' experience or
PhD and 11 years' experience
Pay Range:
$229,600 - $344,400
Disclosure Statement:
The range provided is based on 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 factors including skills, competencies, experience, and other job-related factors permitted by law.
Vertex offers Total Rewards including benefits to meet employees wherever they are in their career, financial, family and wellbeing journey, with resources to support growth and aspirations. Benefits include medical, dental and vision coverage, paid time off, educational assistance programs, student loan repayment, commuting subsidy, charitable donation matching, 401(k), and more.
Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
Hybrid : work remotely up to two days per week;
On-Site : work five days per week on-site with ad hoc flexibility.
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 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.
Application Assistance Applicants needing accommodation in connection with the hiring process or to perform essential functions should contact Talent Acquisition at
ApplicationAssistance@vrtx.com .
#J-18808-Ljbffr