Role 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.
The Director, Medical Operations is a senior cross-functional role within uniQure's Medical Affairs organization, responsible for the operational infrastructure that enables medical strategy execution across US and Global geographies. Reporting directly to the SVP, Medical Affairs, this role provides end-to-end operational leadership across:
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Publication management
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Document and version control
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Medical information systems
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Budget oversight
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Vendor and agency management
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Compliance coordination
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Complex project management support for the Medical Affairs leadership team
The position reports to the SVP of Medical Affairs. We anticipate this role will require up to 30% travel, including to our Lexington office.
Qualifications
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Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (MSc, PharmD, PhD) preferred.
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Minimum 8-10 years of experience in Medical Affairs operations within a pharmaceutical or biotechnology company, small company preferred.
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Proven experience managing Veeva Vault Publications and/or MedInquiries in a Medical Affairs setting.
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Demonstrated experience in publication planning and publication strategy.
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Experience managing multi-regional Medical Affairs operations across US and Global markets.
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Track record of managing Medical Affairs or cross-functional budgets.
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Experience working with external vendors, publication agencies, and med comms partners.
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Familiarity with legal and compliance review processes for Medical Affairs materials.
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Experience in rare disease or gene therapy is highly desirable.
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High proficiency in document management systems and version control methodologies.
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Demonstrated ability to develop and track KPIs and operational metrics dashboards.
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Outstanding project management skills with the ability to manage multiple complex workstreams simultaneously.
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Excellent communication and stakeholder management capabilities, with the ability to operate effectively with senior leadership.
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Collaborative, solution-oriented mindset with a proactive approach to identifying and resolving operational issues.
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Proficiency in Microsoft Office suite and project management tools (e.g. Smartsheet, MS Project).
Requirements
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Support the development and execution of publication strategy in partnership with Senior Director Medical Communications, Director of Publications, and external publication agencies.
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Manage submission workflows, timelines, and author coordination for manuscripts, abstracts, posters, and congress presentations.
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Maintain and enforce publication SOPs and compliance with GPP (Good Publication Practice) guidelines.
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Lead the medical affairs document management function, ensuring robust version control across all medical content.
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Manage congress materials lifecycle β from draft development through review, version control, approval, and archival.
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Maintain document repositories in Veeva and other document management systems, ensuring audit-readiness and compliance.
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Coordinate with Regulatory Affairs, Legal, and Compliance to ensure all Medical Affairs materials undergo appropriate legal and compliance review.
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Coordinate submission of medical information content, ensuring materials are current, approved, and version controlled.
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Monitor inquiry trends and escalate emerging signals to relevant medical and pharmacovigilance stakeholders.
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Own the Medical Affairs operational budget, including forecasting, tracking, purchase order management, and variance reporting.
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Provide structured project management support to the VP Medical Affairs, Senior Medical Communications Lead, and MSL Lead for complex, cross-functional initiatives.
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Ensure operational processes and document management frameworks are adapted and compliant across Global regulatory environments.
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Act as the Medical Affairs system owner for Veeva Vault, managing user access, system governance, and training.
Benefits
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Salary Range: $205,000 - $265,000
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The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job.
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The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.