Vice President, Healthcare Compliance

About the Role

We’re seeking an energetic, versatile, and highly driven compliance leader to join our team as Vice President, Healthcare Compliance. This role is foundational in shaping our healthcare compliance program from the ground up at a pivotal moment in uniQure’s history as we transition from research to commercial stage. The successful candidate will develop and administer all aspects of our global corporate ethics and healthcare compliance program, partnering closely with all departments—including commercial, medical, and market access—to ensure the compliant U.S. launch of our first commercial product.

Reporting to the SVP, Commercial Law and Healthcare Compliance, this role requires superb communication skills, sound judgment, a team mentality, and flexibility to support our compliant and ethical business in a highly regulated environment. It offers meaningful opportunities for professional development and career growth, with the chance to work across all levels of the organization, including senior management.

This is a hybrid position based in Lexington, MA, requiring onsite presence 3 days per week. Some travel (10-25%) may be required, including to our sites in Amsterdam, the Netherlands, and Basel, Switzerland.

Responsibilities

• Contribute to the ongoing design, development, and operationalization of uniQure’s global healthcare compliance program, including policy development, training, risk assessment, and key processes such as transparency reporting, compliance monitoring, and training documentation systems.
• Champion a culture of compliance and ethical decision-making as the company transitions from research to commercial stage.
• Develop and execute a risk-based monitoring and auditing plan for compliance systems, providing periodic assessments and reporting. Post-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 risks, and guide compliant business practices. Empower employees to embrace a compliance mindset through knowledge.
• Develop and deliver engaging, interactive compliance training for commercial, medical, and other teams to ensure understanding of key policies, laws, best practices, and regulatory requirements.
• 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 codes (e.g., PhRMA Code).
• Collaborate with the Commercial Law and Healthcare Compliance team and cross-functional teams to investigate and resolve complex ethics and compliance matters with pragmatic, business-focused solutions.
• Extend the company’s compliance framework for ex-U.S. commercial and pre-commercial activities, including anti-bribery and anti-corruption (ABAC) and interactions with healthcare professionals (HCPs) and organizations (HCOs) in relevant markets.

Qualifications

• BA/BS degree required; J.D., MsJ, or other advanced degree a plus.
• 15+ years of experience in global compliance departments within the biopharmaceutical industry, in both operational and business partnering roles.
• Broad experience in cell or gene therapy, rare disease, or an emerging, publicly traded biopharmaceutical company 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 and timelines in a fast-paced environment with attention to quality and detail.
• Demonstrated ability to operate independently and hands-on in a small company environment without a large existing compliance infrastructure. A “roll up your sleeves” nature is critical.
• Strong interpersonal skills, including proven ability to interact and communicate effectively with individuals at all levels of the organization, including senior leadership.
• Familiarity with EU/EFPIA compliance requirements.
• Commitment to professionalism and ethical conduct, including the ability to handle confidential and/or sensitive information.
• Excellent verbal and written communication skills, enabling open and effective dialogue throughout the company, including with senior leadership.

Pay

Salary Range: $309,000 to $399,000. The actual base salary offered may depend on factors such as qualifications, relevant years of experience, specific skills, education, certifications, and location.

Schedule

This is a hybrid position requiring onsite presence in Lexington, MA, 3 days per week. Travel may be required (10-25%), including to international sites.