Director, Medical Operations

uniQure•Lexington, KY

7d•$205,000 - $265,000•Hybrid

About The Position

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 publication management, document and version control, medical information systems, budget oversight, vendor and agency management, compliance coordination, and 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.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (MSc, PharmD, PhD) preferred.
Minimum 8-10 years of experience in Medical Affairs operations within a pharmaceutical or biotechnology company, small company preferred.
Proven experience managing Veeva Vault Publications and/or MedInquiries in a Medical Affairs setting.
Demonstrated experience in publication planning and publication strategy.
Experience managing multi-regional Medical Affairs operations across US and Global markets.
Track record of managing Medical Affairs or cross-functional budgets.
Experience working with external vendors, publication agencies, and med comms partners.
Familiarity with legal and compliance review processes for Medical Affairs materials.
High proficiency in document management systems and version control methodologies.
Demonstrated ability to develop and track KPIs and operational metrics dashboards.
Outstanding project management skills with the ability to manage multiple complex workstreams simultaneously.
Excellent communication and stakeholder management capabilities, with the ability to operate effectively with senior leadership.
Collaborative, solution-oriented mindset with a proactive approach to identifying and resolving operational issues.
Proficiency in Microsoft Office suite and project management tools (e.g. Smartsheet, MS Project).

Nice To Haves

Experience in rare disease or gene therapy is highly desirable.

Responsibilities

Support the development and execution of publication strategy in partnership with Senior Director Medical Communications, Director of Publications, and external publication agencies.
Manage submission workflows, timelines, and author coordination for manuscripts, abstracts, posters, and congress presentations.
Maintain and enforce publication SOPs and compliance with GPP (Good Publication Practice) guidelines.
Lead the medical affairs document management function, ensuring robust version control across all medical content including scientific platform materials, field tools, public facing portals, and internal reference documents.
Manage congress materials lifecycle — from draft development through review, version control, approval, and archival — across US and Global markets.
Maintain document repositories in Veeva and other document management systems, ensuring audit-readiness and compliance at all times.
Help develop and maintain SOPs and work instructions governing document management and approval workflows.
Coordinate with Regulatory Affairs, Legal, and Compliance to ensure all Medical Affairs materials undergo appropriate legal and compliance review, with version-controlled approval records maintained.
Coordinate submission of medical information content, ensuring materials are current, approved, and version controlled.
Monitor inquiry trends and escalate emerging signals to relevant medical and pharmacovigilance stakeholders.
Ensure operational compliance with global medical information regulations and internal policies, in partnership with Senior Director, Medical Information.
Help train and onboard Medical Affairs team members on Veeva MedInquiry workflows, standards, and Veeva system usage.
Own the Medical Affairs operational budget, including forecasting, tracking, purchase order management, and variance reporting.
Partner with Finance to ensure accurate accruals and timely invoice processing for all Medical Affairs activities.
Provide regular budget performance reporting to the medical affairs team.
Provide structured project management support to the VP Medical Affairs, Senior Medical Communications Lead, and MSL Lead for complex, cross-functional initiatives.
Develop and maintain project plans, timelines, and risk registers for key Medical Affairs workflows.
Facilitate cross-functional alignment meetings, producing clear action logs and ensuring accountability for deliverables.
Identify operational bottlenecks and proactively develop solutions to maintain program momentum.
Support preparation of Medical Affairs senior leadership updates.
Co-lead planning and execution of congress plans, advisory boards, Investigator Initiated Studies, and internal Medical Affairs Plan of Action Meetings.
Ensure operational processes and document management frameworks are adapted and compliant across Global regulatory environments.
Serve as the operational point of contact for Medical Affairs activities requiring multi-regional coordination.
Support harmonization of Medical Affairs processes and systems across geographies, identifying best practices and driving standardization where appropriate.
Maintain awareness of evolving regulatory and compliance requirements across all operating regions.
Act as the Medical Affairs system owner for Veeva Vault (MedComms, Publications and MedInquiry modules), managing user access, system governance, and training.
Develop and maintain KPI and metrics dashboards to track performance across key Medical Affairs operational areas, including publication milestones, inquiry response times, budget utilization, and document turnaround.
Lead continuous improvement initiatives across Medical Affairs operational processes, driving efficiency and compliance.
Oversee onboarding and systems training for new Medical Affairs team members across Veeva Vault and PubStrat document management platforms, and operational workflows.
Partner with IT and Veeva system administrators on system upgrades, validation, and change management.