Director, Internal Audit

Role Summary

The Director of Internal Audit is the internal audit leader for the Company and is responsible for designing, building, and leading a risk-based internal audit function for a growing, publicly traded biopharmaceutical organization. This role provides independent and objective assurance and advisory services focused on governance, risk management, and internal control over financial reporting (ICFR), including Sarbanes-Oxley Section 404 compliance. The Director of Internal Audit will partner closely with executive leadership, the Audit Committee, and cross-functional stakeholders to evaluate and strengthen processes across R&D, G&A, commercial operations, supply chain, and manufacturing. This remote position is based in Colorado, with regular bi-monthly, in person meetings with the Finance team in the Boulder region.

Responsibilities

• Establish, lead, and continuously enhance the internal audit function, including strategy, organizational structure, methodology, and annual risk-based internal audit plan.
• Develop, present, and obtain approval of the annual internal audit and SOX compliance plan; provide regular updates on plan execution, key findings, and remediation status.
• Oversee the Company’s SOX 404 program, including scoping, risk assessment, process documentation, control design and testing, deficiency evaluation, and reporting of internal control over financial reporting.
• Lead and execute (directly and through staff and co-sourced providers) financial, operational, IT, and compliance audits across clinical, commercial, manufacturing, and corporate functions in accordance with professional internal audit standards.
• Provide independent assurance over the design and operating effectiveness of controls in high-risk areas such as revenue recognition, gross-to-net, inventory and COGS, third-party relationships, treasury, payroll, and equity compensation.
• Partner with management to identify, assess, and prioritize key enterprise risks, and ensure the internal audit plan is aligned with the Company’s risk profile and strategic objectives.
• Coordinate and oversee co-sourced or outsourced internal audit providers, ensuring quality, consistency, and value-added recommendations.
• Prepare clear, concise audit reports and presentations that communicate issues, root causes, and practical recommendations to management and the Audit Committee.
• Monitor and report on the status of management action plans to remediate identified control gaps, and validate closure of issues.
• Stay current on evolving regulatory expectations, internal audit and SOX best practices, and industry trends in biotech and life sciences; recommend enhancements to the Company’s governance, risk, and compliance practices.
• Foster a culture of risk awareness, ethical conduct, and continuous improvement through training, communication, and partnership with business leaders.
• Build, lead, and develop a high-performing internal audit team; provide coaching, mentorship, performance feedback, and career development opportunities.
• Direct supervisory responsibility for internal audit staff and manages relationships with co-sourced or outsourced internal audit providers.

Skills

• Deep knowledge of internal auditing standards, risk-based auditing, and internal control frameworks (e.g., COSO).
• Strong expertise in Sarbanes-Oxley (SOX) 302/404 compliance, including ICFR design, testing, and remediation.
• Significant experience in a publicly traded biopharmaceutical, biotech, or life sciences company, preferably with exposure to both clinical and commercial operations.
• Proven ability to develop and execute a risk-based internal audit plan and to communicate results effectively to management and the Audit Committee.
• Strong understanding of financial reporting processes, U.S. GAAP, and key areas of risk such as revenue recognition, inventory, COGS, and third-party programs.
• Highly skilled in assessing processes, identifying control gaps, and developing pragmatic, value-added recommendations.
• Exceptional communication, presentation, and influencing skills, with the ability to build trust and collaborate across all levels of the organization.
• Demonstrated leadership in building, managing, and developing high-performing teams and effectively overseeing co-sourced audit partners.
• High degree of integrity, objectivity, professional skepticism, and commitment to ethical business practices.
• Proficiency with ERP and financial systems (e.g., NetSuite) and experience leveraging data analytics and automation tools to enhance audit coverage and insight.

Education

• Bachelor’s degree in Accounting, Finance, Business Administration, or a related field is required; an advanced degree is a plus.
• Professional certification such as CPA, CIA, or CISA is strongly preferred.

Additional Requirements

• Travel: This position requires up to 10% travel. Frequently travel is outside the local area and overnight.