Executive Director, Device Development

Xeris Pharmaceuticals•Chicago, IL

4d•Onsite

About The Position

The Executive Director, Device Development is responsible for providing executive level, strategic oversight of Xeris’ combination product and device development function. This role will manage the intersection of our proprietary XeriSol and XeriJect technology platforms with the advanced delivery systems required to provide Xeris’ highly optimized combination products. The Executive Director will assume strategic and operational leadership over all combination product commercial and development functions, bridging critical cross-functional gaps between engineering, clinical, quality, regulatory, and commercial functions to ensure our combination products hit key program milestones. This position is vital to optimizing department resource management, accelerating communication protocols, and ensuring strict deadline adherence on highly visible corporate projects. The position will directly manage existing device engineering resources, elevating the function by instituting rigorous work-organization frameworks and proactive data-sharing across CMC, clinical, quality, and regulatory stakeholders. The Executive Director is responsible for development of products according to Xeris’ Design Controls and Quality By Design (QbD) development processes. Program work will include all aspects of drug delivery and associated container/closure system development. While Xeris may use partners to co-develop combination products, the Executive Director will manage these business relationships and ensure Xeris’ goals and objectives are met. The Executive Director is also responsible for ensuring the accurate and timely compilation of the relevant Regulatory CMC Module sections, Device History File (DHF), Quality Target Product Profile, specifications and support for associated submissions.

Requirements

Master’s degree in Biomedical or Mechanical Engineering or similar discipline and a minimum of 18 years of experience working with pharmaceuticals / biopharmaceuticals
A minimum of 15 years of experience in a GMP pharmaceutical/biopharmaceutical environment with drug delivery medical device experience
Subject Matter Expertise in the development and commercialization of delivery devices and combination products
Comprehensive expertise with drug and device regulations in support of FDA and EU submissions
Expertise in engineering documentation and guidelines (i.e. ISO & ASTM)
Expertise in device Quality Management Systems (i.e.21CFR820 & ISO 13485)
Expertise in Drug Product cGMPs (i.e. 21CFR210/211)
Expertise in FDA Design Controls and cGMP principles and work environment
Experience in CAD Software or SOLIDWORKS
Experience with QbD principles in general and specifically as they relate to device development
Delivery Device Project Management experience from Proof-of-Concept Stage to Commercialization
Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications

Responsibilities

Establish the strategies for the design and development activities for new and existing drug/device products to ensure they meet quality, regulatory and internal Xeris standards
Develop, lead, and retain a high-performing device engineering organization by attracting top talent, fostering employee engagement and professional growth, building leadership capability, and creating an inclusive, accountable culture that enables exceptional technical execution and program success.
Remain current on applicable regulations, guidances and standards that drive Xeris’ combination products programs.
Represent the drug delivery function at an executive level on cross-functional development and commercial teams as well as meetings with external partners
Provide oversight in determining the technical design criteria for each program
Provide oversight of all drug delivery development and commercialization aspects for Xeris’ combination products
Oversee translation of product requirements into specifications
Manage and oversee device design development in accordance with specifications and applicable guidelines/regulations
Ensure the robustness of new products through product launch
Establish strategies and provide expert level input to development teams for pre- and post- commercial manufacturing
Oversee the work of cross-functional teams to solve complex combination product related issues
Ensure work is completed in compliance with approved quality and regulatory standards
Ensure proper oversight of development, manufacturing and testing operations at contract sites
Establish and oversee the device development related aspects of the departmental budget
Review and ensure the accuracy, completeness, and compliance of the device sections for combination Drug Product sections of the eCDT for INDs and NDAs/BLAs