Director, Combination Product Program Lead

The posting, as Praxis Precision Medicines, Inc. wrote it

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 produ

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rapies 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.

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