Director of Ethics and Compliance

Director of Ethics and Compliance

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

Position Summary:

We are seeking a strategic, experienced, and values-driven Director, Ethics & Compliance, to establish and lead our company's first Ethics & Compliance (E&C) function. As the organization expands its biosimilar and branded product portfolio, this role will serve as a key partner to the business, ensuring ethical conduct, regulatory compliance, and a culture rooted in integrity.

This is a hands-on, high-impact leadership role responsible for designing and implementing an effective E&C program tailored to the unique needs of a growing, dynamic organization. You will bring a forward-thinking, pragmatic, and risk-aware mindset to help the company navigate a complex healthcare landscape while enabling innovation and operational agility.

Payrate is determined by considering a person's prior experience and competence. The pay range for this position is $190,000 to $230,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Build and Lead the Ethics & Compliance Function
  Establish the company's foundational E&C program, including policies, procedures, training, monitoring, and governance frameworks.
• Regulatory Compliance and Risk Mitigation
  Ensure the company's practices comply with applicable U.S. laws, FDA rules and regulations, industry codes, and internal standards, with an eye toward global regulatory readiness.
• Strategic Business Partnership
  Serve as a trusted advisor to senior leadership and functional teams, providing clear guidance on ethical decision-making, regulatory risks, and compliance expectations.
• Culture and Values Leadership
  Champion a values-based culture by promoting transparency, ethical behavior, and responsible business practices across all levels of the organization.
• Program Development and Execution
  Design and implement risk assessments, training programs, reporting channels, and investigation protocols appropriate for a high-growth specialty product organization.
• Innovation-Driven Compliance
  Leverage digital tools, data analytics, and technology solutions to modernize compliance processes and support business agility.
• Cross-Functional Collaboration
  Partner with Legal, Regulatory, Medical Affairs, Commercial, and other functions to ensure seamless integration of compliance into key business processes.
• Global Expansion Planning
  Prepare the compliance infrastructure to scale, ensuring readiness to meet evolving regulatory and ethical standards.
• Monitoring and Continuous Improvement
  Implement internal controls and audit mechanisms to monitor program effectiveness, drive continuous improvement, and address emerging risks proactively.

Supervisory - None

Competencies

• Business Acumen
• Judgement
• Change Management
• Project Management
• Ethics
• Interpersonal

Qualifications

• JD or advanced degree preferred.
• 10+ years of progressive experience in Ethics & Compliance or Legal roles, preferably in the life sciences or healthcare sector.
• Deep understanding of U.S. healthcare regulatory requirements (e.g., FDA, OIG, DOJ, PhRMA Code); experience with ex-U.S. compliance frameworks a plus.
• Demonstrated ability to build and scale E&C programs from the ground up.
• Proven track record of acting as a strategic advisor and influencing senior leadership.
• Strong business acumen with the ability to balance compliance and innovation.
• Experience in specialty pharmaceuticals or complex product environments is highly desirable.
• Excellent communication, collaboration, and leadership skills.
• Ability to navigate ambiguity and drive change in a fast-paced, entrepreneurial environment.
• Experience handling or advising through business crises or high-risk situations preferred.

What We Offer

• Opportunity to build a compliance function from day one and shape the ethical foundation of a growing company.
• Collaborative, mission-driven culture focused on innovation and patient impact.
• Competitive compensation and benefits with room for future growth and leadership.

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.