Director, Commercial Compliance
About The Position
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.
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.
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.
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 your coverage
- dollar-for-dollar up to 6% on eligible 401(k) contributions
- long-term stock incentives and ESPP
- discretionary quarterly bonus
- extremely flexible wellness benefit
- generous PTO, paid holidays and company-wide shutdowns
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
