Director, Commercial Compliance

Role Summary

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

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 supporting 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.

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

• Required: 5+ years of experience in commercial compliance, legal, regulatory, or promotional review within biopharma; CNS, neurology, or rare disease experience preferred.
• Required: Experience building or scaling commercial and/or corporate compliance programs. First launch or early commercial build-out experience preferred.
• Required: Hands-on participation in MLR/Promotional Review Committees.
• Required: Strong knowledge of FDA advertising and promotion regulations, OPDP guidance, and corporate compliance principles for commercial operations.

Education

• Bachelor’s degree; advanced degree preferred (JD, PharmD, MD, PhD, or MPH)

Additional Requirements

• The physical and mental requirements of the role include regular use of a computer and 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.