Praxis Precision Medicines, Inc. · 16 hours ago
Director, Commercial Compliance
United States
Full-time
Remote
Lead/Staff, Director/Executive
$200K/yr - $225K/yr
5+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Director of Commercial Compliance will build and lead the U.S. commercial compliance program, ensuring alignment with regulations while supporting business agility in anticipation of product launches.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
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
Qualification
Required
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
Preferred
advanced degree preferred (JD, PharmD, MD, PhD, or MPH)
CNS, neurology, or rare disease experience preferred
First launch or early commercial build-out experience preferred
Benefits
99% of the premium paid for medical, dental and vision plans
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage
Match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
An extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
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.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-02-03
Company data provided by crunchbase