Vice President, Healthcare Compliance

• Contribute to the ongoing design, development and operationalization of uniQure’s global healthcare compliance program, including policy development, training, risk assessment, and development of key processes and programs, such as transparency reporting, compliance monitoring, and training documentation systems, in advance of and following the Company’s first launch.

• Champion a culture of compliance and ethical decision making across the organization as the Company transitions from a research stage to commercial stage culture.

• Develop and execute a risk-based monitoring and auditing plan of compliance systems, providing periodic assessments and reporting; upon product approval, conduct of 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 through knowledge, employees to embrace a compliance mindset

• Develop and deliver compliance engaging and interactive training for commercial, medical and other teams to ensure understanding of key policies, laws, best practices, regulatory requirements and ethical standards

• Serve as a subject matter expert on healthcare fraud and abuse 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 within the Commercial Law and Healthcare Compliance team, and with cross functional teams, to investigate and resolve complex ethics and compliance matters with pragmatic, business focused solutions.

• Support investigations where applicable and appropriate.

• Extend the Company’s compliance framework for ex-US commercial and precommercial activities, including ABAC and interactions with HCPs and HCOs in relevant markets.

• BA/BS degree required; J.D., MsJ or other advanced degree a plus

• 15+ years’ experience in global compliance departments in the biopharmaceutical industry, in both operational and business partnering roles. Broad experience in cell or gene therapy or rare disease, or in an emerging, publicly traded biopharmaceutical company environment is a plus.

• Direct experience in creating and enhancing right-sized compliance programs. Prior experience designing and building a corporate compliance program for a biopharmaceutical company through its initial commercial launch is highly preferred.

• Ability to manage multiple tasks timelines in a fast-paced environment with attention to quality and detail.

• Demonstrated ability to operate independently and in a hands on manner in a small company environment, without a large existing compliance infrastructure. A “roll up your sleeves” nature is critical to success in this role.

• Strong interpersonal skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization, including senior leadership.

• Familiarity with EU/EFPIA compliance requirements

• Commitment to professionalism and ethical conduct, including ability to handle confidential and/or sensitive information.

• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company, including to senior leadership.

• Ability to travel up to 10- 25% of the time