[Hiring] Director, Combination Product Program Lead @Praxis Precision Medicines

Role Description

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

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.
• Demonstrable FDA device regulatory experience.
• Electrical engineering foundation.
• Drug and device fluency.
• Proven leadership and individual contribution.
• Cross-functional influence.
• Executive presence.
• Highly desirable — technical breadth in:
• 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.
• High EQ.
• Strong work ethic.
• Thrives in a transparent, performance driven culture.
• Sense of urgency.

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.
• Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage.
• 401(k) contributions matched dollar-for-dollar up to 6%.
• Long-term stock incentives and ESPP.
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous PTO, paid holidays, and company-wide shutdowns.

Annualized Base Salary

$205,000 - $225,000 USD

Company Description

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.