CARB-X COMPLIANCE DIRECTOR, CARB-X

CARB-X is the largest externally-funded program at Boston University reporting to the Vice President and Provost for Research. CARB-X is a global non-profit partnership dedicated to accelerating antibacterial research and development to tackle the threat of drug-resistant bacteria. The CARB-X portfolio is the world's most promising early development pipeline of innovative products to prevent, diagnose and treat life-threatening bacterial infections. CARB-X is grant-funded and currently supported by multiple government and foundation funders. The CARB-X environment is innovative, dynamic, energetic, and rapidly evolving. The Compliance Director is a member of the Operations Team and leads the compliance team at CARB-X. This leadership role is responsible for designing, directing and continuously improving CARB-X's compliance program across regulatory, research, contractual, and organizational domains. The position provides strategic oversight of regulatory alignment with US and international standards (including animal and human subjects research requirements), compliance by CARB-X and portfolio companies with multiple funder agreements, risk management, grant applicant due diligence and policy governance. Serving as CARB-X's primary compliance authority for regulators, auditors, and funders, this leader manages high-risk issue escalation, ensures readiness for regulatory review and audit, and guides the development of policies, SOPs, and governance frameworks. The role also leads and mentors a multidisciplinary compliance team while fostering cross-team collaboration and a culture of ethical conduct, transparency and continuous improvement. Success in this position requires substantial experience navigating a complex grant-funded global research environment and deep expertise in research compliance regulations, strong strategic and operational judgment, and the ability to effectively engage external stakeholders. The Compliance Director works in close partnership with the CARB-X Chief Operating Officer, providing strategic counsel on organizational risk, regulatory obligations, and operational integrity to ensure CARB-X meets its commitments to funders, partners, and global stakeholders. Financial compliance will remain the purview of the Finance & Research Administration Team.

Essential functions include: Leadership of the CARB-X Compliance Program

• Provide overall leadership, vision and direction for CARB-X's compliance program, encompassing regulatory, research, contractual, governance and operational compliance. Establish long-term goals, monitoring systems, training frameworks, and organizational priorities and develop and steward a unified compliance strategy that ensures CARB-X meets all governmental and private regulatory expectations.
• Exercise clear decision-making authority within the compliance function, proactively identifying issues, applying sound judgment and strong problem-solving skills, and escalating material risks or unresolved matters as appropriate.
• Drive timely resolution of compliance challenges through active engagement and hands-on leadership, ensuring accountability and execution rather than passive coordination.
• Work closely with the COO to ensure the compliance strategy supports organizational priorities and informs executive-level decision-making.

Oversight of Research Compliance Programs, including Animal and Human Subjects Research

• Provide oversight for compliance activities related to human subjects research (HSR), animal research, and research integrity across all product developers and performance sites. Ensure institutional consistency, risk mitigation, regulatory readiness, and alignment with OLAW, NC3Rs, IRBs (or equivalent), IACUCs (or equivalent), and funder requirements.
• Oversee and collaborate with the Assistant Director, Research Compliance and ensure appropriate resource allocation, prioritization, and issue escalation pathways.

Enterprise Risk Management, Due Diligence, and High-risk Issue Resolution

• Direct risk identification and mitigation across legal, financial, operational, and research activities. Escalate significant risks, proposed resolutions, and strategic tradeoffs to the COO to support timely, informed decision-making. Oversee due diligence processes.
• Review high-risk compliance concerns surfaced by the Compliance Manager, Assistant Director, Research Compliance, Alliance Leads, FRA team, or BU Sponsored Programs. Lead crisis management and decision-making for compliance escalations and propose resolutions to executive leadership.

Governance, Regulatory Alignment, and Award/Contract Negotiation

• Lead the development, approval, and maintenance of compliance policies, SOPs, and governance documentation for CARB-X. Serve as CARB-X's primary institutional representative to external regulatory bodies and auditors, overseeing regulatory engagement and leading communications related specifically to escalations, audits, and material compliance matters.
• Ensure CARB-X's policies and processes align with evolving federal and international research requirements. Represent CARB-X in contract and award negotiations and on compliance matters.

Oversight of Conflicts of Interest, Confidentiality, and Regulatory Reporting Frameworks

• Provide leadership oversight for CARB-X's conflicts of interest program, confidentiality and data integrity systems, and compliance reporting obligations.
• Ensure consistency across teams, quality assurance of compliance-related documentation, and effective audit preparation.
• Approve escalated or sensitive COI/HSR/animal research issues and determine risk-based approaches or exceptions as appropriate.

Cross-functional Leadership, Staff Development, and Organizational Integration

• Lead, collaborate with, and mentor the compliance team. Provide technical direction, performance feedback, and professional development.
• Serve as key advisor to the COO on compliance-related operational planning, resourcing, and organizational culture.
• Align cross-departmental processes involving BU's Office of General Counsel, Sponsored Programs Office and Research Compliance Office, as well as CARB-X FRA, R&D, EA and Operations teams. Promote a culture of compliance, ethical research, transparency, and continuous improvement across CARB-X.

Required Skills
Required: Bachelor's Degree Preferred: Advanced degree such as Master's, PhD or JD and/or relevant professional certifications such as CPIA (Certified Professional in IACUC Administration), CHRC (Certified in Healthcare Research Compliance), CHC (Certified in Healthcare Compliance), RAC (Regulatory Affairs Certification), CIP (Certified IRB Professional), CRA (Certified Research Administrator). Experience in lieu of preferred credentials will be considered. In addition:

• 10-12+ years of progressively responsible compliance experience, including multiple areas such as human subjects research compliance (IRB, FWA); animal research compliance (IACUC, OLAW Assurance, IIAs, NC3Rs); sponsor/regulatory compliance for federally funded research; organizational compliance (COI, confidentiality, and regulatory reporting), contracts or due diligence review in a research or biotech environment.
• 5+ years in a leadership or management role, supervising staff or leading cross-functional teams.
• Demonstrated experience developing policy frameworks, compliance governance structures, and risk mitigation strategies at the organizational level. Experience navigating international research regulations (non-US animal welfare and human research standards), or working with foreign CROs/AROs, strongly preferred. Experience in a scientific research environment, such as biotech, pharma, academic research administration, federal contracting programs, or global health organizations.
• Expert knowledge of US federal and international (specifically EU and Australian) research compliance regulations, including: OLAW, PHS Policy, Guide of the Care and Use of Laboratory Animals, IIAs, Foreign Assurance requirements; Common Rule, IRB standards, FWAs, IRB approvals, GCP; HHS, NIH BARDA requirements.
• Strong understanding of international research regulatory frameworks, or the ability to rapidly interpret and apply them. Familiarity with contractual compliance, due diligence, risk analysis, and governance processes. Ability to develop and interpret policies, SOPs, and guidance documents at a high level.
• Proficiency with research compliance systems and document management platforms (e.g. Salesforce, Box, audit logs).
• Demonstrated ability to lead, collaborate with, and develop high-performing teams, including staff with scientific, regulatory and administrative backgrounds. Strong strategic thinking, able to anticipate regulatory changes and organizational needs. Excellent judgment, decision-making skills, and ability to evaluate complex, multistakeholder compliance issues. Proven ability to collaborate effectively across departments such as General Counsel, Sponsored Programs, Research Compliance, Finance, R&D and external partners. Superb written and verbal communication skills: capable of preparing materials for funders, regulators, auditors, and executive stakeholders. High level of professional integrity, ethical standards, and commitment to responsible research conduct.
• Experience working with or in organizations that manage large, distributed research portfolios or involve complex international collaborations. Familiarity with biotech, drug development, or preclinical research environments is significant advantage. Experience representing an organization to regulators, auditors, or federal funders. Ability to travel domestically and internationally as needed.

The position can be entirely virtual, but must be able to work (at least partially) in ET and CET time zones.