Director, Combination Product Program Lead

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

Location: United States

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

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. This is the single most important requirement. 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.

Why Praxis

You will lead a technically ambitious, first-of-its-kind program with direct line of sight to executive leadership and to patient impact. You will work alongside talented internal teams, a specialist technology partner, and expert consultants — with the autonomy to drive and the accountability to match.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people and their people is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Attention: Job Scam Alert

Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [e-mail].

Annualized Base Salary

$205,000—$225,000 USD