Director, Drug–Device Program Lead

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 205,000 - 225,000; Full time

Job summary

Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program from design through regulatory submission. You will bridge pharmaceutical development and device engineering, coordinating with internal teams, a technology partner, and consultants.

You will personally lead critical technical work, own timelines and risk, and present progress to executive leadership with urgency and rigor. This role requires remote work with occasional travel.

Qualifications

• Direct combination product leadership experience across device and drug development.
• Demonstrable FDA device regulatory experience with design controls and submissions.
• Electrical engineering foundation with hands-on hardware/software problem solving.

Responsibilities

• Own the program end-to-end from device design to DHF ownership and risk management.
• Shape FDA regulatory strategy for the combination product and ensure inspection readiness.

Skills

Drug-device leadership

FDA regulatory

Electrical engineering

Cross-functional leadership

Program management

Tools

Regulatory strategy

Job description

Praxis Precision Medicines, Inc. seeks a Program Leader to drive a drug-device combination program from design through regulatory submission. You will bridge pharmaceutical development and device engineering, coordinating with internal teams, a technology partner, and consultants.

You will personally lead critical technical work, own timelines and risk, and present progress to executive leadership with urgency and rigor. This role requires remote work with occasional travel.