Director, Combination Product Program Lead

Role: Lead technical program management for a drug-device combination product integrating therapeutics with an advanced dermal delivery platform. Objectives include driving device design, verification, risk management, and maintaining regulatory compliance from early development through clinic readiness. Responsibilities encompass end-to-end program ownership, shaping FDA regulatory strategy, ensuring alignment between drug and device development, managing multidisciplinary teams internally and externally, and contributing hands-on expertise in electronics, software, electrochemistry, or hardware. Requirements: Extensive experience leading drug-device combination development, with demonstrable FDA regulatory success; background in electrical engineering or related technical field; fluency in pharmaceutical and device quality systems (ISO 13485, ISO 14971, IEC 62366); strong leadership with cross-functional influence and communication skills. Preferred: Hands-on skills in electronics, embedded hardware, software, electrochemistry, or wearable delivery systems. Experience in design history file ownership or end-to-end documentation is highly valued. High-Value: Focus on combination product development, FDA pathways, and technical depth in electronics, software, or wearable device engineering. Work setup: Remote with travel flexibility. The role reports to senior leadership, emphasizing high visibility and strategic impact in advancing innovative therapeutics.