Remote Senior Director, Drug–Device Program

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 205,000 - 225,000; Full time

Job summary

Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program, bridging drug development and device engineering.

The role combines hands-on technical work with strategic leadership across regulatory, quality, clinical, and operations to move the program toward the clinic. The position offers high visibility, requires FDA regulatory experience and strong electrical engineering foundations, and includes a base salary range of $205,000–$225,000 USD.

Qualifications

• Led technical development of drug-device combination products end-to-end
• Experience taking devices or combination products through FDA regulatory processes
• Background in electrical engineering with practical depth
• Understanding of ISO 13485, ISO 14971, IEC 62366, IEC 60601

Responsibilities

• Own the program end to end from device design through DHF ownership and milestones
• Lead the FDA regulatory pathway and ensure submission readiness
• Bridge pharmaceutical development and device engineering to keep timelines aligned
• Unite a multidisciplinary Praxis team across scientific, regulatory, quality, clinical, and operations
• Partner with external device and regulatory consultants to maintain momentum
• Contribute hands-on across electronics, software, electrochemistry, and delivery hardware
• Communicate progress, risks, and decisions to executive leadership with urgency

Skills

Direct combination product leadership

FDA regulatory experience

Electrical engineering foundation

Drug and device fluency

Leadership and individual contribution

Cross-functional influence

Executive presence

Job description

Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program, bridging drug development and device engineering.

The role combines hands-on technical work with strategic leadership across regulatory, quality, clinical, and operations to move the program toward the clinic. The position offers high visibility, requires FDA regulatory experience and strong electrical engineering foundations, and includes a base salary range of $205,000–$225,000 USD.