Vice President, Healthcare Compliance

uniQure•Lexington, KY

2d•$309,000 - $399,000•Hybrid

About The Position

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. We’re seeking an energetic, versatile, and highly driven compliance leader to join our team as Vice President, 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 SVP, Commercial Law and Healthcare Compliance, the VP, Healthcare 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. This is a foundational opportunity to help shape a healthcare compliance program from the ground up at a pivotal moment in uniQure’s history. 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, balancing compliance rigor against the practical realities of a company preparing for its first launch. This is a highly cross-functional, hands-on role, suitable for someone who has built or scaled a compliance program before, not just administered an existing one. This role is best suited for a dynamic compliance leader who is energized by the ambiguity and pace of a small biotech heading into its first launch, who has 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.

Requirements

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

Nice To Haves

J.D., MsJ or other advanced degree a plus
Broad experience in cell or gene therapy or rare disease, or in an emerging, publicly traded biopharmaceutical company environment is a plus.
Prior experience designing and building a corporate compliance program for a biopharmaceutical company through its initial commercial launch is highly preferred.

Responsibilities

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.