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Job Description
General Summary:
The Clinical Supply Planning Manager is responsible for planning, forecasting and allocation of devices, constituents and process aids 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, forecasting and allocation of devices, constituents and process aids for Vertex's Type 1 Diabetes program
- Works with contract manufacturing partners by developing forecasts for production and sterilization of constituents and process aids
- 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 OPM 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 Site Supply Chain to ensure production, sterilization and delivery schedules and priorities are aligned
- Works with cross functional team including Clinical Operations and CMC to develop program wide supply plan
- Manages the allocation of devices and constrained materials from Providence or associated contract manufacturers
Knowledge and Skills:
- Experience in working with CMC Teams
- Work experience must include some of the following: drug development, project management, planning, medical device manufacturing/packaging
- Good working knowledge of regulations relating to clinical labeling, manufacturing and packaging activities (CGMP, GCP)
- Knowledge of Oracle, PowerBI and Smartsheet
- Experience in Clinical Supplies/Supply Chain, Clinical Operations, Quality, or CMC role in a Biotech, Pharmaceutical, or CRO company
- Superb interpersonal, communication and customer relations skills
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.
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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.