Director, US Compliance – Business Partner (Biopharma)

TL;DR

Director, US Compliance – Business Partner (Biopharma): Leading compliance strategy and partnership for US business functions with an accent on risk-based guidance for rare disease and gene therapy programs. Focus on embedding compliance as a strategic enabler during clinical development and commercialization phases.

Location: Remote (USA)

Salary: $185,000 - $252,500 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Partner with Neuro and Other Rare Program Teams to provide proactive, risk-based guidance on laws and industry standards.
• Serve as a subject matter expert throughout the product lifecycle, from clinical trials and launch to post-market activities.
• Oversee implementation of mitigation plans and support the Internal Investigation Committee for compliance-related items.
• Develop and facilitate compliance training (e-learning and live) and update departmental Policies and SOPs.
• Review functional materials including presentations, HCP materials, and data dashboards.
• Promote a continuous improvement mindset for the Compliance Program based on industry trends.

Requirements

• Bachelor’s Degree and 10+ years of experience in US Healthcare.
• Significant experience in US HCC for a pharmaceutical or biotech company.
• In-depth knowledge of OIG guidelines, AMA guidelines, PhRMA Code, Anti-Kickback, False Claims Act, and US transparency laws.
• Proven experience building and managing compliance programs in a growing commercial biotech environment.
• Must be based in the USA.
• Ability to travel occasionally (5%–15%).

Nice to have

• HCC Certifications.
• Direct experience working within a Gene Therapy organization.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including mental health support and wellbeing reimbursement.
• 401(k) plan with competitive company match, annual equity awards, and ESPP.
• Generous paid time off, fertility/family-forming benefits, and flexible work schedules.
• Access to Company Learning Institute with LinkedIn Learning, leadership programs, and mentorship.
• Employee resource groups and meaningful opportunities to volunteer and give back.