Position Overview

We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.

Key Responsibilities

Regulatory Compliance & Risk Management

• Experienced with the compliance aspects of clinical trial & clinical research
• Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
• Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
• Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
• Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
• Monitor evolving AI regulations and their impact on clinical trial optimization platforms

Quality Management & Documentation

• Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance 
• Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
• Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
• Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection

Contract & Vendor Compliance

• Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
• Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
• Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
• Support commercial team with compliance aspects of customer onboarding and due diligence processes

Training & Cross-Functional Support

• Develop and deliver compliance training programs for employees across all functions
• Serve as primary compliance liaison with external auditors, regulators, and certification bodies
• Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
• Maintain compliance calendar and ensure timely completion of regulatory filings and renewals

Required Qualifications

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
• OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
• Direct experience with clinical trial regulations and GCP requirements
• Proven track record managing compliance programs in regulated industries

Technical Expertise

• Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
• Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
• Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
• Financial compliance awareness including regulatory reporting requirements
• Deep knowledge of GDPR and HIPAA requirements and implementation
• Hands-on experience with SOC 2 audits and information security compliance frameworks
• Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
• Understanding of AI/ML regulatory landscape in healthcare and clinical trials

Core Competencies

• Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
• Excellent written and verbal communication skills for regulatory correspondence and training delivery
• Project management experience with ability to manage multiple compliance initiatives simultaneously
• Detail-oriented approach with strong documentation and process improvement capabilities

Preferred Qualifications

• Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
• Experience with international regulations (EU Clinical Trials Regulation, other global markets)
• Background in clinical research or pharmaceutical compliance
• Familiarity with AI ethics and algorithmic bias considerations in healthcare
• Experience with healthcare technology or SaaS compliance programs