Director, Internal Audit

•  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.

1.       Deep knowledge of internal auditing standards, risk-based auditing, and internal control frameworks (e.g., COSO).

2.      Strong expertise in Sarbanes-Oxley (SOX) 302/404 compliance, including ICFR design, testing, and remediation.

3.      Significant experience in a publicly traded biopharmaceutical, biotech, or life sciences company, preferably with exposure to both clinical and commercial operations.

4.      Proven ability to develop and execute a risk-based internal audit plan and to communicate results effectively to management and the Audit Committee.

5.      Strong understanding of financial reporting processes, U.S. GAAP, and key areas of risk such as revenue recognition, inventory, COGS, and third-party programs.

6.      Highly skilled in assessing processes, identifying control gaps, and developing pragmatic, value-added recommendations.

7.      Exceptional communication, presentation, and influencing skills, with the ability to build trust and collaborate across all levels of the organization.

8.      Demonstrated leadership in building, managing, and developing high-performing teams and effectively overseeing co-sourced audit partners.

9.      High degree of integrity, objectivity, professional skepticism, and commitment to ethical business practices.

10.  Proficiency with ERP and financial systems (e.g., NetSuite) and experience leveraging data analytics and automation tools to enhance audit coverage and insight.

• 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.
• 12+ years of progressive experience in internal audit, risk management, and/or public accounting, with at least 5 years in a leadership role (Senior Manager level or above).   Prior experience in a publicly traded biopharmaceutical, biotech, or life sciences company is strongly preferred.
• Demonstrated experience leading SOX 404 compliance programs and working closely with external auditors and Audit Committees.
• Background in a Big 4 or large public accounting firm and/or corporate internal audit leadership in a complex, global environment is highly desirable.
• Proven ability to build and scale internal audit functions, including implementing risk-based audit methodologies, technology enablement, and best practices.