Praxis

Director, Commercial Compliance

Praxis

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $200,000 - $225,000 per year

Job Level

Lead

About the role

  • 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.
  • 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.

Requirements

  • 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 include regular use of a computer, devices or office equipment, clear communication, and occasional movement with reasonable accommodations for individuals with disabilities.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance.
  • AD&D, disability benefits, and voluntary plans to personalize coverage.
  • 401(k) contributions matched dollar-for-dollar up to 6%.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Extremely flexible wellness benefit.
  • Generous PTO and paid holidays.
  • Company-wide shutdowns.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
compliance program designrisk assessmentregulatory reviewpromotional reviewcompliance trainingdata use compliancemonitoring activitiesinvestigation and remediationMLR processescorporate compliance controls
Soft Skills
clear communicationcollaborationtrainingadvisory skillsproblem-solvingorganizational skillsstakeholder engagementtimelinessleadershipinterpersonal skills
Certifications
Bachelor's degreeJDPharmDMDPhDMPH