Director, Commercial Compliance

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

The Opportunity

We’re seeking a Director of Commercial Compliance to build and lead Praxis’s U.S. commercial compliance program in anticipation of up to two potential product launches. This is a foundational role that will shape a scalable, fit-for-purpose, risk-based compliance framework to enable high-integrity, patient-centric commercialization while support business agility.

You’ll operate as a strategic partner across Legal, Regulatory, Medical Affairs, Finance, and Commercial, and serve as a core member of the Promotional Review Committee (MLR) where you’ll provide regulatory, legal, and compliance guidance on promotional materials and activities.  You’ll be expected to lead with clarity, make decisive calls, and co-create solutions that uphold our values while enabling speed and impact in a compliant manner.

Primary Responsibilities

• Design, implement, and scale Praxis’s commercial compliance program in advance of first launch, including policies, SOPs, governance, risk assessment, monitoring and training.
• Establish launch-ready corporate compliance controls supporting commercial operations, including:
• HCP interactions (speaker programs, advisory boards, consulting)
• Transparency and reporting (e.g., Sunshine Act / Open Payments)
• Patient support, access, and hub-related activities
• Commercial contracting, transfers of value, and third-party oversight
• Serve as a standing MLR member, providing regulatory, legal, and compliance review of promotional materials.
• Ensure alignment with FDA regulations, OPDP guidance, and company standards.
• Partner with Commercial and Medical teams to enable efficient, compliant review and messaging.
• Define MLR processes, timelines, precedents, and escalation pathways.
• Train internal stakeholders on promotional compliance, scientific exchange, and appropriate data use.
• Advise on compliant use of clinical, safety, and real-world data across promotional and non-promotional channels.
• Conduct launch-focused compliance risk assessments and implement monitoring activities.
• Support investigation and remediation of commercial compliance issues in partnership with Legal and HR.

Qualifications and Key Success Factors

• Bachelor’s degree; advanced degree preferred (JD, PharmD, MD, PhD, or MPH)
• 5+ years of experience in commercial compliance, legal, regulatory, or promotional review within biopharma - CNS, neurology, or rare disease experience preferred.
• Experience building or scaling commercial and/or corporate compliance programs.  First launch or early commercial build-out experience preferred.
• Hands-on participation in MLR/Promotional Review Committees.
• Strong knowledge of FDA advertising and promotion regulations, OPDP guidance, and corporate compliance principles for commercial operations.
• 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.

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.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.