Director, Combination Product Program Lead New United States - Remote

Praxis Precision Medicines, Inc.; United States; Remoto; USD 205.000 - 225.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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

Mansioni

• 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

Conoscenze

Direct combination product leadership

FDA regulatory experience

Electrical engineering foundation

Drug and device fluency

Leadership and individual contribution

Cross-functional influence

Executive presence

Descrizione del lavoro

United States - Remote

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
• 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.

To round out our world‑class total rewards package, we provide annualized base salary in the range listed below. This range reflects the base salary the Company reasonably expects to pay for the position at the time of posting. Placement within the range will be based on job‑related factors, including experience, qualifications, scope of responsibilities, and demonstrated track record of delivering results in similar roles.

$205,000 - $225,000 USD

Compensation & Benefits

At Praxis, we believe that taking care of our people (and

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.