Executive Director, Device Development

Xeris Pharmaceuticals Inc; Kentucky; On-site; USD 274,000 - 365,000; Full time

Benefits offered by this job

Equity incentive

Annual bonus

Comprehensive benefits

401(k) plan

Job summary

Xeris Pharmaceuticals, Inc. is seeking an Executive Director, Device Development to provide strategic oversight of the device development function, bridging engineering, clinical, quality, regulatory, and commercial teams to reach key milestones.

This role leads a high-performing device engineering organization and ensures design controls and QbD processes guide development. The position manages drug delivery device programs end-to-end, collaborates with partners, and drives submission readiness

Qualifications

• Master’s degree in Biomedical or Mechanical Engineering and 18+ years in pharma/biopharma.
• Minimum 15 years in GMP pharma/biopharma with drug delivery device experience.
• Expertise in development and commercialization of delivery devices and combination products.
• Regulatory expertise for FDA/EU submissions and quality systems.

Responsibilities

• Establish design and development strategies for new and existing drug/device products.
• Lead and retain a high-performing device engineering organization.
• Stay current on applicable regulations, guidances, and standards.
• Represent drug delivery at executive level with cross-functional teams and external partners.
• Oversee technical design criteria and device development in line with specs.

Skills

GMP experience (pharma/biopharma)

Drug delivery device development

Regulatory submissions (FDA/EU)

QbD principles

FDA Design Controls

ISO 13485 knowledge

Project management

CAD software / SOLIDWORKS

Cross-functional leadership

Education

Master’s degree in Biomedical or Mechanical Engineering (or similar)

Tools

SOLIDWORKS

Job description

Job Description: 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.

Essential Job Functions

• 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

Skills and Qualifications

• 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

Competencies

• Results-oriented
• Attention to Detail
• Interpersonal skills
• Verbal and Written Communication skills
• Project Management
• Analytical skills

Working Conditions

Position may require travel and periodic evening and weekend work, as necessary to fulfill obligations and meet corporate goals. Occasional overnight travel may be required. This position is based in Xeris’ Chicago office and requires five days per week on site.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The anticipated base salary range for this position is $273,600 - $364,800. We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable.

Benefits

• Employees are eligible for equity or long-term incentive awards, where applicable.
• Field Sales role employees are eligible for a quarterly commission structure.
• Non-Sales role employees are eligible for an annual bonus.
• The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits and more for eligible employees.

Accessibility & Reasonable Accommodations If, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to [e-mail] and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose, you will not receive a response to your email. Do not include any medical or health information in this email.

Xeris participates in E-Verify.

Xeris Pharmaceuticals, Inc. (the “Company”) is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company’s employment selection decisions are based solely on job-related factors.

Xeris Pharmaceuticals, Inc. (the “Company”) is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company’s employment selection decisions are based solely on job-related factors.