Cristcot

Compensation

Full Description

Job Summary The Senior Director, Compliance will lead Cristcot’s comprehensive compliance program as the company launches its inaugural ulcerative colitis (UC) therapy. This strategic and operational role champions compliance as the top organizational priority, embedding integrity, risk mitigation, and ethical decision-making across all functions in a highly regulated environment. The Senior Director owns end-to-end leadership of the Medical, Legal, Regulatory (MLR) review process for promotional, non-promotional, scientific, educational, training, and field materials. It provides enterprise-wide oversight for market access contracting (payer agreements, rebates, pricing, government programs) while establishing, owning, and continuously enhancing company-wide SOPs, policies, and training programs, particularly focused on enabling Commercial (sales representatives) and Medical teams (MSLs, medical affairs) to engage compliantly with HCPs, external congresses, and stakeholders. Primary Relationships Within Cristcot, the Senior Director, Compliance – Commercial and Medical will partner strategically with leadership, Legal, Regulatory, Medical Affairs, Marketing, Market Access, Pricing/Reimbursement, Sales, Operations, and all functions. Outside Cristcot, the Senior Director, Compliance – Commercial will engage with external vendors, congress/conference organizers, HCPs (for compliance guidance), regulatory authorities (FDA/OPDP/CMS support), and industry bodies. Primary Job Responsibilities The Senior Director, Compliance – Commercial and Medical will serve as a trusted advisor to executive and cross-functional leadership, driving proactive risk management, monitoring, and culture initiatives, this position ensures Cristcot maintains the highest standards of regulatory and ethical compliance (without providing legal or regulatory interpretations). The activities of the Senior Director, Compliance – Commercial and Medical will include, but are not limited to: 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. Skills and Qualifications: 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%.