Device Project Management Director

Job Description

General Summary:

The Device Project Management Director will be accountable for directly and indirectly leading the development and execution of the end-to-end program and project plans. The scope includes cross-functional project and portfolio management for the development of the device constituent of Vertex's pipeline of combination products across multiple therapy areas and routes of administration including inhalation, implantation, and injection.

Key Duties and Responsibilities:

• Lead highly complex, large-scale internal and external new product development programs.
• Develop detailed schedules, DHF management, define objectives and goals for the different, sub-projects/workstreams, and individual team members.
• Facilitation of cross-functional team workshops to map current state processes, identify opportunities and define solutions.
• Proactively lead the team to identify and assess areas of risk, escalate issues in a timely manner, and collaboratively develop thorough contingency, mitigation, and other risk retirement plans.
• Establish strong working relationships with diverse functional areas to understand cross-functional inputs and interdependencies for combination product development
• Effective stakeholder management and change management for buy-in and integration of processes, deliverables, technologies and roles/responsibilities into existing teams and infrastructure.
• Define and direct budgets for multiple programs including resource loading, external expenses, and capital requirements.

Knowledge and Skills:

• Design Controls in accordance with ISO 13485, EU MDR, FDA Title 21 CFR Part 4, and FDA 21 CFR Part 820.
• Risk management per ISO 14971 including user, process and design FMEA's
• Project management discipline to develop plans, define scope, design controls, DHF management and manage budget/schedule/resources
• Drive the development and tracking of roadmaps, project schedules, risks/mitigation plans, deliverables, and KPI's.
• Communicate program status, program readiness, business and technical issues, risks and their resolution across Engineering, including senior management

Education and Experience:

• Doctorate degree & 4 years of Project Management experience OR
• Master's degree & 5 years of Project Management experience OR
• Bachelor's degree & 8 years of Project Management experience AND significant experience with project management tools and technology in the healthcare industry.

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