Senior Director, Compliance

Job Description

At uniQure, we are delivering on the promise of gene therapy and delivering hope for patients facing urgent unmet medical needs. Every role in our organization carries profound purpose; whether you're in research, operations, access, or support, your contributions impact patients. We're seeking passionate professionals who thrive in high-stakes environments, uphold rigorous quality standards, and share our relentless commitment to transforming the lives of patients. Join us in making the impossible possible, where your expertise becomes a catalyst for life-changing treatments.

Key Result Areas (Major Duties, Accountabilities and Responsibilities)

We’re seeking an energetic, versatile, and highly driven compliance leader to join our team as Senior Director, Healthcare Compliance. The successful candidate will help develop and administer all aspects of our global corporate ethics and healthcare compliance program and partner closely with all departments including commercial, medical, and market access, to ensure the successful and compliant U.S. launch of our first commercial product. Reporting to the VP, Commercial Law and Compliance, the Senior Director, Compliance, will work with all levels of employees, including senior management. The role requires superb communication skills, sound judgment, a team mentality, and flexibility to support our compliant and ethical business in this highly regulated space, with meaningful opportunities for professional development and career growth.

The ideal candidate for this role will be comfortable partnering with multiple business units to implement various initiatives that ensure adherence to uniQure policies, laws, and industry guidance and best practices. This involves close collaboration with the internal business teams to ensure an understanding of their needs and to foster a trusted partnership around compliance matters. As a key advisor and resource, the individual must have the appropriate level of business acumen, judgment and experience to advise the business on complex legal and business matters in a highly regulated environment.

This role is best suited for a dynamic compliance leader with demonstrated ability to partner effectively with a growing and evolving organization in order to achieve business goals while mitigating compliance risks, and who is a strategic, analytical thinker, approaching issues in a pragmatic and efficient manner and communicating solutions clearly and concisely.

• Contribute to the ongoing design, development and operationalizing of uniQure’s global healthcare compliance program, including policy development, risk assessment, and development of key processes and programs, such as transparency reporting, compliance monitoring, and training documentation systems.
• Monitor and audit compliance systems, providing periodic assessments and reporting; upon product approval, conduct field monitoring, including field rides, and attendance at promotional, educational, and congress events.
• Partner across all departments to promote and enhance a culture of compliance and integrity, identify and mitigate compliance risks, and guide compliant business practices; empower employees to embrace a compliance mindset through knowledge.
• Develop and deliver engaging and interactive compliance training for commercial, medical and other teams to ensure understanding of key policies, laws, best practices, regulatory requirements and ethical standards.
• Develop and maintain knowledge of key laws, regulations, and industry guidance, including the Anti-Kickback Statute, False Claims Act, Federal Sunshine Act, and various state laws and industry guidance (e.g., PhRMA Code).
• Collaborate with the VP, Commercial Law and Compliance, and other functions, to investigate and resolve complex ethics and compliance matters, including support of investigations where necessary.

Qualifications & Skills

• BA/BS degree required; J.D., MsJ or other advanced degree a plus.
• 10+ years’ experience in global compliance departments in the biopharmaceutical industry, in both operational and business partnering roles. Broad experience in an emerging, publicly traded biopharmaceutical company environment is a plus.
• Experience in creating and enhancing right-sized compliance programs. Prior experience implementing a corporate compliance program for a biopharmaceutical company through its initial commercial launch is highly preferred.
• Ability to manage multiple tasks and timelines in a fast-paced environment with attention to quality and detail.
• Strong interpersonal skills, including the proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization, including senior leadership.
• Commitment to professionalism and ethical conduct, including the ability to handle confidential and/or sensitive information.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Ability to travel up to 10-25% of the time.

This is a hybrid position. The company is located in Lexington, MA. We are looking for someone who will be onsite in Lexington 3 days per week. Some travel may be required, including to the company’s other sites located in Amsterdam, The Netherlands, and Basel, Switzerland.