Associate Director, Clinical Supply Chain
The Associate Director, Clinical Supply Chain has broad external influence within established global supply networks and will foster interdisciplinary understanding and integrate activities both within and outside the Supply Chain organization. The Associate Director of Clinical Supply Chain will lead the overall management of Cell and Gene Therapy supply chain activities required to support clinical studies. In this role, will act as a liaison between Clinical Operations and VCGT. The Associate Director will review and organize existing clinical study documents, lead study start-up activities including protocol review, supply assessment, drug product label text preparation, comedication sourcing, packaging, and labeling. Within this role, the Associate Director will ensure there are robust processes, clear communication, and cross-functional alignment for all clinical studies. The Associate Director will work closely with key stakeholders including the Clinical Operations, Finance, Regulatory, Logistics, Manufacturing, and Vertex’s Cell and Gene Therapy teams.
This is a Boston based, hybrid position (3 days/week onsite).
- Ownership of Clinical Supply Chain activities associated with the provision of Clinical Trial Material for a given protocol, such as meetings, TMF review/filing, sourcing, packaging, labeling, and distribution.
- Serves as the Clinical Supply Chain representative on matrix teams for complex projects to actively participate in the review of protocols, development of project plans, setting project priorities, and providing input on timing, resources, and budget projections.
- Design and approve clinical labels for all regions.
- Forecast, Source, label & distribute comedications/nIMPs as required per clinical protocols.
- Manage relationships with vendors for sourcing, labeling, and distribution of study drug.
- Oversee quality issues related to the clinical supply chain, including deviations, CAPA, and change control.
- Interacts with Finance to develop budgets and manage costs for clinical supply chain activities.
- Executes project statements for defined activities and assists with multi-year supply agreement contract negotiation.
- Supports the Supply Chain team’s development of Cell and Gene Therapy strategies including vendor selection and program scalability.
- Utilizes appropriate software and IT systems to effectively manage key project activities.
- Takes full responsibilities within scope of the position to manage work with various cross-functional groups (such as Quality, Clinical Operations, Regulatory, suppliers, etc.)
- Develops and revises SOPs to support supply chain activities.
- Mentors junior supply chain staff and directs activities of other staff members.
- Works with supervisor to develop tools and standards for department functions.
- Works with Finance and Legal to develop multi-project budgets and large multi-project work statements with contract manufacturing partners.
- Interacts with Finance to develop budgets and manage costs for clinical supply activities.
- Key contributor to the development of global supply and procurement strategies
Education and Experience:
- Requires 8 years of experience in a Biotech, Pharmaceutical or CRO company and 2 years of supervisory/management experience, or the equivalent combination of education
- Capability to build cross-functional alignment.
- Excellent verbal, written and presentation skills and effectively communicate with all levels of management.
- Demonstrated expertise in critical thinking, influence, negotiation, problem solving, strategic thinking and leadership in a matrix environment.
- Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
- Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
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.