Director, Drug-Device Program Leadership

Praxis Precision Medicines; United States; Remote; USD 205,000 - 225,000; Full time

Job summary

Praxis Precision Medicines is seeking a Program Leader to drive a drug-device combination product from design through to clinic, blending hands-on engineering with strategic regulatory leadership.

The role requires direct technical leadership across device and pharmaceutical domains, strong FDA regulatory experience, and a background in electrical engineering to ship impactful, compliant programs.

Qualifications

• Directly led technical development of drug-device products across design, verification, validation and risk management.
• Proven track record with FDA and design controls for combination products or devices.
• Strong electrical engineering background with hands-on technical depth.
• Working knowledge of ISO 13485, ISO 14971, IEC 62366 and related standards.
• Experience leading cross-disciplinary teams and external partners with measurable outcomes.

Responsibilities

• Own the program end-to-end from device design to DHF ownership and timelines.
• Lead regulatory strategy and ensure submissions are prepared and inspection-ready.
• Bridge pharmaceutical development and device engineering for synchronized progress.
• Unite multidisciplinary Praxis teams across science, regulatory, quality, clinical and ops.
• 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 clearly to executive leadership.

Skills

Combination product leadership

FDA regulatory experience

Electrical engineering

Drug-device fluency

Leadership and IC

Cross-functional influence

Executive presence

Job description

Praxis Precision Medicines is seeking a Program Leader to drive a drug-device combination product from design through to clinic, blending hands-on engineering with strategic regulatory leadership.

The role requires direct technical leadership across device and pharmaceutical domains, strong FDA regulatory experience, and a background in electrical engineering to ship impactful, compliant programs.