Executive Director, Device Development
Xeris Pharmaceuticals, Inc.
August 22, 2026
On-site
Chicago, IL
Operations
Responsibilities:
- Provide executive strategic/operational oversight of Xeris combination product and device development (XeriSol/XeriJect) and manage cross-functional execution across engineering, clinical, quality, regulatory, and commercial teams.
- Lead drug delivery and associated container/closure system development using Design Controls and Quality by Design (QbD).
- Establish design/development strategies; translate product requirements into specifications; oversee device design development to applicable guidelines/regulations.
- Oversee drug delivery development and commercialization; ensure product robustness through launch.
- Manage partner co-development relationships and ensure program goals/objectives are met.
- Ensure accurate, timely Regulatory CMC module compilation (e.g., DHF, Quality Target Product Profile, specifications) and support submissions (INDs/NDAs/BLAs).
- Oversee contract site development/manufacturing/testing; manage device development budget; review eCDT device sections for compliance.
Qualifications:
- Master’s in Biomedical/Mechanical Engineering (or similar) + 18+ years pharma/biopharma experience.
- 15+ years GMP pharma/biopharma experience with drug-delivery medical device experience.
- Subject matter expertise in development/commercialization of delivery devices and combination products.
- Comprehensive FDA/EU drug and device regulatory expertise; strong engineering documentation knowledge (ISO/ASTM).
- Expertise in device QMS (21 CFR 820, ISO 13485) and drug product cGMPs (21 CFR 210/211); FDA design controls and cGMP principles.
- Experience with CAD (e.g., SOLIDWORKS) and QbD; project management from proof-of-concept to commercialization.
Skills:
- Results-oriented; attention to detail; strong communication; project management; analytical skills.
- Provide executive strategic/operational oversight of Xeris combination product and device development (XeriSol/XeriJect) and manage cross-functional execution across engineering, clinical, quality, regulatory, and commercial teams.
- Lead drug delivery and associated container/closure system development using Design Controls and Quality by Design (QbD).
- Establish design/development strategies; translate product requirements into specifications; oversee device design development to applicable guidelines/regulations.
- Oversee drug delivery development and commercialization; ensure product robustness through launch.
- Manage partner co-development relationships and ensure program goals/objectives are met.
- Ensure accurate, timely Regulatory CMC module compilation (e.g., DHF, Quality Target Product Profile, specifications) and support submissions (INDs/NDAs/BLAs).
- Oversee contract site development/manufacturing/testing; manage device development budget; review eCDT device sections for compliance.
Qualifications:
- Master’s in Biomedical/Mechanical Engineering (or similar) + 18+ years pharma/biopharma experience.
- 15+ years GMP pharma/biopharma experience with drug-delivery medical device experience.
- Subject matter expertise in development/commercialization of delivery devices and combination products.
- Comprehensive FDA/EU drug and device regulatory expertise; strong engineering documentation knowledge (ISO/ASTM).
- Expertise in device QMS (21 CFR 820, ISO 13485) and drug product cGMPs (21 CFR 210/211); FDA design controls and cGMP principles.
- Experience with CAD (e.g., SOLIDWORKS) and QbD; project management from proof-of-concept to commercialization.
Skills:
- Results-oriented; attention to detail; strong communication; project management; analytical skills.