Senior Manager Medical Device Program Lead

Job Summary:

In this position you will be leading several device development projects, from concept to commercial production, across several therapeutic areas for biosimilar drugs. You will bridge the business and technical worlds by bringing a combination of strong planning, orchestration and communication skills, collaborating with cross‑functional experts involved in devices’ definition, development and manufacturing, and acting as a key contributor to the biosimilar project development team.

• Lead cross‑functional exercises to define targeted device profiles
• Develop device development project plans and budgets with internal and external cross‑functional teams
• Deliver quality products and processes with appropriate validation and regulatory documentation
• Report and tightly control device development timelines, budgets and risks to the biosimilars project development team
• Act as the main interface between the biosimilars project development teams and the subteams (e.g., medical devices, manufacturing & supply) as well as device vendors and service providers (HF, Test laboratories)
• Provide technical and business inputs to projects. Analyze risks and suggest mitigation plans
• Oversee device development, manufacturing, validation and regulatory activities
• Proactively anticipate and identify risk areas and alert stakeholders appropriately
• Report and escalated potential issues to management as needed
• Identify new device opportunities
• Lead innovation and/or continuous improvement projects

• Bachelor’s degree (or equivalent) in Product Design, Mechanical, Process, Materials Science or Electronic Engineering
• 5+ years of experience in project management
• 10+ years of experience in device development with an understanding of device safety, regulatory requirements, policies and procedures
• Deep technical understanding of device design, validation, verification and their link to other drug development activities (clinical, manufacturing, commercial, etc.) in the overall drug development plan
• Experience in FDA‑regulated medical devices, standalone CE‑marked devices and combination drug‑device products
• Track record of resolving issues in a matrix organization
• Strong interpersonal and relationship‑building skills with the ability to establish a trusted role with various stakeholders
• Solid organizational skills including attention to detail and multi‑tasking abilities
• Effective verbal and written communication skills
• Fluent in English, both oral and written; additional languages (German or French) are an asset