Sr. Director, Ethics & Compliance

The Role

The Senior Director, Ethics and Compliance, is a leader on our Ethics and Compliance team and a member of the US Leadership Team. Reporting to the Chief Ethics, Compliance & Privacy Officer, with strong partnership with senior leaders across Legal, Commercial, Medical, Clinical, Regulatory, Manufacturing, Development, IT, Finance and HR to build and integrate appropriate local compliance controls with our global compliance program. This role will be responsible for establishing US compliance strategy and guidance to enable Moderna’s commercial and medical organizations while collaborating and coordinating with the Global compliance team. The ideal candidate will have deep US compliance experience and prior experience building local compliance programs at a global pharmaceutical company. This individual will also exhibit exceptional dynamic range, capable of quickly pivoting between global strategy and local operational execution, with a relentless focus on ensuring that the team can meet the needs of Moderna as it continues to scale.

Here’s What You’ll Do:

• Act with urgency: Establish strong working relationships quickly, ensuring that timely, thoughtful advice on compliance is given to key departments such as Commercial, Medical Affairs, and Clinical operations. Recognize that proactive compliance measures today can prevent significant issues tomorrow.

• Pursue options in parallel: Lead the US Compliance Committee while simultaneously engaging with the Executive Committee and the Board, evaluating multiple strategies and technologies to enhance the compliance program, making informed decisions that balance immediate needs with long-term goals.

• Accept risk: Develop and implement US compliance strategies that recognize the inherent risks in the pharmaceutical industry, embracing these risks as necessary for impactful innovation and progress.

• Obsess over learning: Continually seek knowledge in US compliance trends and global best practices, fostering a culture where rapid learning and adaptation are key to staying ahead in a dynamic regulatory environment.

• Pivot fearlessly: Be prepared to adjust US compliance strategies and operations in response to new data, regulatory changes, or internal audit findings, ensuring that the organization remains agile and compliant.

• Question convention: Challenge existing compliance models and practices, driving innovation in how Moderna approaches ethics and compliance to better serve the evolving landscape of the pharmaceutical industry.

• Push past possible: Drive the compliance team to achieve beyond standard expectations, fostering a culture where striving for excellence is the norm and where comfort zones are expanded to reach new heights of compliance and integrity.

• Behave like owners: Treat the company's compliance needs as personal responsibility, going beyond the job description to build a robust and integrated program that reflects the ownership mindset at every level.

• Act with dynamic range: Seamlessly transition between setting strategic compliance visions at the global level and executing operational tasks at the local level, demonstrating versatility and effectiveness in both areas.

• Remove viscosity: Streamline processes and communication channels within the compliance team and across departments, promoting swift and coordinated action that aligns with Moderna's collective goals.

• Prioritize the platform: Focus on strengthening the overall compliance framework that supports all of Moderna's products and services, ensuring that the platform is robust, scalable, and adaptable to the company's growth.

• Digitize everywhere possible: Leverage digital technologies and data analytics to enhance the compliance program, using digital tools to maximize efficiency, transparency, and the impact of compliance initiatives on patient safety and company integrity.

Here’s What You’ll Need (Minimum Qualifications)

• Bachelor's degree required.  MBA preferred.

• 12+ years of relevant global commercial, compliance and/or legal experience

•  7+ years of experience in a leadership position in a highly regulated industry, preferably in biopharma or life sciences industries

• Experience managing US Compliance function for a multinational organization

• Experience working in a heavily matrixed global organization

• Proven success in leading teams

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Working knowledge of relevant US compliance guidelines, regulations (AKS, FCA, FDCA, HIPAA, FCPA) and PhRMA Code principles

• Proven experience in balancing country-level operational priorities with global compliance program devel