Program Leader, Drug-Device Combination Product

Praxis is advancing a novel device combination product that pairs one of our proprietary investigational therapeutics with an advanced dermal delivery platform. We are seeking a Program Leader with hands-on technical leadership experience on drug-device combination products to drive this cross-organizational effort to the clinic.

This is a high visibility role for a technically deep leader who can operate as both a decisive program driver and a hands-on individual contributor. You will be the connective tissue between our internal scientific, regulatory, and clinical teams, our technology partner, and our external device and regulatory consultants, keeping a demanding program moving with pace, rigor, and clarity.

Primary Responsibilities

• Own the program. Drive the drug device combination program end to end, from device design and verification through risk management and design history file ownership, setting strategy, building integrated timelines, managing risk, and holding the line on scope, quality, and deadlines.
• Lead the regulatory pathway. Shape the FDA regulatory strategy for the combination product, coordinating device and drug considerations and ensuring the program stays inspection ready and submission ready at every stage.
• Bridge drug and device. Translate fluently between pharmaceutical development and device engineering so that both halves of the combination product advance in lockstep.
• Unite a multidisciplinary team. Align and mobilize colleagues across disciplines and seniorities within Praxis, scientific, regulatory, quality, clinical, and operations, without necessarily holding direct authority over all of them.
• Partner externally. Operate as the trusted day-to-day interface with our technology partner, ensuring smooth collaboration, clear accountability, and shared momentum. Direct and integrate the work of external device and regulatory consultants.
• Contribute hands-on. Roll up your sleeves on technical problem solving across electronics, software, electrochemistry, and delivery hardware, not just delegate it.
• Communicate up. Present progress, risks, and decisions crisply to executive leadership, and bring an appropriate sense of urgency to the room.

Key Success Factors

• Direct combination product technical leadership. You have personally led the technical development of a drug-device combination product, spanning device design and engineering, verification and validation, human factors, and combination product risk management, not just directed others doing that work. You can point to specific combination products or delivery systems you have taken from early development through design transfer, submission, or launch.
• Demonstrable FDA device regulatory experience. A track record of taking devices or combination products through FDA regulatory processes (e.g., 21 CFR Part 4, design controls, premarket submissions), with concrete evidence of that experience.
• Electrical engineering foundation. A background or experience in working in electrical engineering projects (or closely related), with genuine technical depth rather than a purely managerial view.
• Drug and device fluency. A working understanding of both pharmaceuticals and devices, and how they come together, including combination product quality systems (ISO 13485), risk management (ISO 14971), human factors / usability engineering (IEC 62366), on-body / wearable delivery system requirements (ISO 11608, including Part 6), and medical electrical equipment safety (IEC 60601).
• Proven leadership and individual contribution. Evidence that you can lead people and programs while also delivering technical work yourself.
• Cross-functional influence. Demonstrated ability to coordinate diverse, skilled specialists and to work smoothly with external partners and consultants.
• Executive presence. Comfort and credibility presenting to and being challenged by senior leadership.

Highly desirable — technical breadth

We would be especially excited by candidates who bring hands-on strength in one or more of the following:

• Electronics and embedded hardware design
• Software / firmware development
• Electrochemistry as applied to delivery or sensing
• Human implantable or body worn device development
• On-body, wearable, or transdermal delivery device development
• Direct ownership of a combination product design history file (DHF), technical file, or design control documentation, end to end

How you work

• Agile. Comfortable operating iteratively, adapting quickly, and making progress amid ambiguity.
• High EQ. Reads people and situations well, builds trust across organizations, and defuses friction before it slows the program.
• Strong work ethic. Takes ownership, follows through, and holds a high bar for yourself and the program.
• Thrives in a transparent, performance-driven culture. Gives and receives direct feedback, is measured on outcomes, and values candor.
• Sense of urgency. Understands that timelines matter and moves accordingly, without sacrificing quality or compliance.