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

About the Role

We're looking for a driven, detail-oriented Clinical Contracts Specialist to join our small but mighty Legal team. In this role, you will manage and negotiate clinical trial agreements with sponsors and biotech partners, serving as a key point of contact throughout the contract lifecycle. Through your organization, communication skills, and daily dedication, you will have a meaningful impact on the success of our clinical partnerships and, ultimately, on the patients we serve.

Responsibilities

• Draft, review, and negotiate clinical trial agreements (CTAs), confidentiality agreements (CDAs), and related documents with sponsors and biotech partners
• Serve as the primary point of contact for external parties on contract status, redlines, and execution timelines
• Manage the contract lifecycle in Ironclad, including tracking pending agreements, maintaining version control, and ensuring timely follow-ups
• Route finalized agreements for signature and maintain organized records of executed contracts
• Collaborate with clinical, business development, and finance teams to align contract terms with operational and budgetary requirements
• Identify and escalate contractual issues or non-standard terms to the Director of Legal for resolution
• Drive excellence and efficiency by maintaining templates, playbooks, and standard operating procedures for clinical contracting
• Support audit and compliance requests by ensuring contract documentation is complete and accessible

What We're Looking For

• Bachelor's degree in Life Sciences, Legal Studies, Business, or a related field
• 3+ years of experience negotiating or administering clinical trial agreements, preferably within a sponsor, CRO, or healthcare technology company
• Proficiency with contract lifecycle management systems (Ironclad preferred; Agiloft, Concord, or similar acceptable)
• Strong understanding of clinical research processes and regulatory considerations (e.g., ICH-GCP, HIPAA)
• Excellent written and verbal communication skills with the ability to manage multiple external stakeholders
• You are highly organized and adept at managing time-sensitive work streams and competing priorities
• You are a team player who dives head first into accepting diverse and challenging assignments with rigor and tenacity
• You have high integrity and excellent judgment

What We Offer

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off

Our Commitment to Diversity

At Iterative Health, we're building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.