Director, Combination Product Program Lead

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.

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 View email address on click.appcast.io .

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Create a Job Alert

Interested in building your career at Praxis Precision Medicines, Inc. ? Get future opportunities sent straight to your email.

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School Select...

Degree Select...

Select...

LinkedIn Profile

Have you applied for employment with Praxis previously? * Select...

Are you a former Praxis employee, or have you performed any work for us (in any capacity) in the past? * Select...

Are you 18 years of age or older? * Select...

If extended an offer of employment, are you willing to submit to a background check? * Select...

This position requires flexibility and willingness to travel as needed. Are you able to meet this requirement? * Select...

Do you have any family members who are currently employed/have been employed by Praxis Precision Medicines, Inc.? * Select...

Are you authorized to work in the United States (with or without sponsorship)? * Select...

Do you now or in the future require sponsorship to work in the United States? * Select...

Do you currently have any existing commitments or non-compete/non-solicit agreements in place that would delay your ability to begin employment with Praxis? * Select...

Applicants must read the description below in full, and provide authorization and acknowledgement to proceed with submission of an application for employment at Praxis Precision Medicines, Inc. * Select...

Authorization and Acknowledgment

I certify that the information provided in this application (and any accompanying résumé or documents) is true, complete and correct. I understand that any false statements, omissions, or misrepresentations may result in the rejection of my application or, if employed, dismissal from employment.

I authorize Praxis Precision Medicines, Inc. (“Praxis”) to verify the information provided and to contact former employers, schools, and references regarding my background. I hereby waive any and all rights and claims I may have against Praxis for seeking, gathering, verifying and/or using such information in the employment process.

I understand it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

I acknowledge that any offer of employment may be contingent on the successful completion of reference checks, background checks, or other requirements as permitted by law. I also understand that if I am hired, I will be required to provide proof of my identity and legal authority to work in the United States and that federal immigration laws require me to complete an I-9 Form in this regard.

I understand that this application does not constitute a contract of employment. If hired, my employment will be “at will,” meaning that either I or Praxis may terminate the employment relationship at any time, with or without cause or notice, subject to applicable law.

By submitting my information, I acknowledge that I have read, understood, and agree to the above statements.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Praxis Precision Medicines, Inc. ’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

#J-18808-Ljbffr