Director, Compliance

Iterative Health•Cambridge, NY

About The Position

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Director, Compliance 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.

Requirements

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
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
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

Nice To Haves

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

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