Associate Director, Device Development (Combination Products)

Location: South San Francisco, United States; hybrid arrangement with on-site work at least three days per week and approximately 10% travel to partner sites in the U.S. and abroad

Salary: $190,000–$220,000 per year

Company

Clinical-stage biotechnology company developing therapies for genetically validated cardioendocrine diseases, including severe hypertriglyceridemia and acromegaly.

What you will do

• Lead device development for combination product configurations from clinical development through Phase 3, BLA submission, and commercial readiness.
• Own device design controls, including user needs, design inputs, risk management, verification, human factors, and development files.
• Direct external design partners, device suppliers, test laboratories, and clinical assembly and packaging CMOs.
• Lead primary and secondary packaging development, container closure integrity testing, and shipping and distribution simulations.
• Define device contributions to stability and shelf-life studies in collaboration with Drug Product and Analytical teams.
• Author and review device content for IND amendments, IMPDs, BLA submissions, and health authority interactions.

Requirements

• B.S. with 10+ years, M.S. with 8+ years, or Ph.D. with 6+ years of relevant combination product or drug delivery device development experience.
• Hands-on experience developing prefilled syringe and autoinjector combination products through design verification and Phase 3.
• Working knowledge of 21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62366-1, and the ISO 11608 series.
• Experience directing external design firms, platform suppliers, test laboratories, and CMOs in an outsourced operating model.
• Ability to write technical protocols, reports, and regulatory content, including statistically justified sample sizes and acceptance criteria.
• Excellent written, oral, and interpersonal communication skills.

Nice to have

• BLA or NDA device development experience.

Culture & Benefits

• Hands-on, collaborative environment with direct involvement across organizational levels.
• Full-time hybrid work with regular on-site collaboration in South San Francisco.
• Approximately 10% travel to external partner sites, with potential increases during critical builds and studies.