Descrição
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.
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.
- 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
- 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:
- 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