Please contact your Administrator to change your authorization settings.
Job Description
General Summary:
The Clinical Supply Chain Manager is responsible for forecasting, packaging, labeling and distribution of investigational medicinal product to support Vertex clinical studies. This role delivers on independent activities and acts as the primary Supply Chain contact on working teams and with key contract manufacturing/logistics suppliers.
Key Duties and Responsibilities:
- Ownership of Clinical Supply Chain activities including planning, labeling, packaging and distribution of Investigational Medicinal Product for multiple projects
- Works with contract manufacturing partners
- Forecasting supply needs in conjunction with Clinical and CMC colleagues
- Works with Finance to develop budgets and manage costs for clinical supply activities
- Supports the Supply Chain team's development of global supply and procurement strategies including vendor selection
- Utilizes appropriate software and IT systems, including IWRS and Quality/Document Management Systems to support key project activities
- Displays effectiveness in managing customer expectations and influencing others
- Develops and revises SOPs to support supply chain activities
- Works with CMC team to design packaging and stability needs
- Works with cross functional team including Clinical Operations and CMC to develop program wide supply plan
Knowledge and Skills:
- Demonstrated experience in project management and managing, tracking, and measuring project progress
- Experience in working with CMC Teams
- Work experience must include some of the following: drug development, project management, clinical trials management, pharmaceutical manufacturing/packaging
- Good working knowledge of regulations relating to clinical labeling, packaging and distribution activities (CGMP, GCP)
- Knowledge of Interactive Voice/Web response systems for use in clinical studies
- Experience in Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
Education and Experience:
- Bachelor's degree (or equivalent experience) and 4+ years of relevant experience
- Experience working in a pharmaceutical environment and/or in Clinical Supplies, or the equivalent combination of education and experience.
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
#LI-Hybrid
#LI-BS1
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.
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 Human Resources at ApplicationAssistance@vrtx.com.