Senior Director, Compliance – Commercial and Medical
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Job Description
Senior Director, Compliance responsible for compliance strategy in pharmaceutical launches. Leading integrity and ethical decision-making processes across regulatory environments.
Responsibilities:
- Lead the compliance program to develop, implement, and own the overall compliance strategy, positioning compliance as a core value and top priority at Cristcot.
- Establish and own company-wide SOPs and policies, enabling best practices across the organization that cover promotional review, scientific/educational activities, field operations, contracting, and more.
- Own and strategically lead MLR/PRC processes: Oversee end-to-end MLR workflow Chair/co-chair PRC meetings; ensure efficient support for both promotional (sales/marketing) and non-promotional/scientific/educational materials.
- Design and deliver targeted compliance training & education for Commercial and Medical teams.
- Provide compliance oversight for market access and contracting: Lead review and risk mitigation for payer agreements, rebate contracts, pricing programs, and government program compliance (e.g., Medicaid Best Price, AMP calculations, transparency reporting), including red-flag screening and documentation.
- Drive risk management, monitoring, and continuous improvement Monitor regulatory landscape and lead adaptations: Stay ahead of FDA (OPDP), CMS, PhRMA, DOJ, and other guidance; proactively update SOPs, processes, and training to maintain compliance in a dynamic environment.
- Lead investigations and audit readiness inclusive of overseeing deviation investigations, root-cause analysis, corrective/preventive actions; maintain audit-ready records for MLR, contracts, training, field activities, and rebates/payments; support audits/inquiries.
- Serve as strategic advisor and cross-functional partner with business-oriented compliance guidance to senior leaders and teams; collaborate to align priorities, enable compliant innovation, and foster ethical decision-making across the organization.
Requirements:
- Bachelor’s degree in life sciences, regulatory affairs, compliance, healthcare administration, business, law, or related field (advanced degree such as JD, PharmD, MBA strongly preferred).
- 10-15+ years of progressive experience in pharmaceutical/biotech compliance, with significant leadership in MLR/PRC processes, healthcare compliance programs, market access/contracting oversight, and training development in launch or highly regulated environments.
- Deep expertise in FDA promotional rules (21 CFR Parts 202/314, OPDP guidance), fair balance, PhRMA Code, Anti-Kickback Statute, False Claims Act, Medicaid/Medicare rules, Sunshine Act, and related regulations.
- Proven track record establishing company-wide SOPs/policies and positioning compliance as a strategic priority.
- Hands-on experience with MLR platforms (Veeva Vault PromoMats or equivalent) and contract/rebate systems.
- Demonstrated success designing/delivering compliance training for sales representatives and medical affairs teams, including congress/conference-specific content.
- Strong strategic thinking, executive presence, project management, analytical, communication, and influence skills; ability to balance hands-on execution with high-level leadership in a small company.
- High ethical standards, attention to detail, and comfort in a fast-paced, growth-oriented setting.
- Ability to travel <15%.
Benefits:
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
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