Director, Combination Product Program Lead

United StatesRemotelead

OtherDirector

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Quick Summary

Overview

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

Technical Tools

OtherDirector

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.

Responsibilities

~1 min read

→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.

Requirements

~1 min read

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.

Annualized Base Salary

$205,000—$225,000 USD

What We Offer

~2 min read

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 careers@praxismedicines.com.

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.