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Senior Director, Medical Information

uniQure
Full-time
Remote friendly (United States)
Worldwide
Medical Affairs

Senior Director, Medical Information

Job Description

uniQure is dedicated to bringing innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The Senior Director, Medical Information will lead our Medical Information. This role will build comprehensive medical information capabilities from the ground up, overseeing development and execution of medical information strategy to ensure provision of accurate, balanced, and timely scientific information to healthcare professionals, patients, and internal stakeholders. Reporting to the SVP of Medical Affairs, you will define the vision for Medical Information to achieve the highest-level service and customer satisfaction.

The position reports to the SVP, Global Medical Affairs. We anticipate this role will require up to 15% travel including to our Lexington office.

Key Result Areas (major duties, accountabilities and responsibilities)

Strategic Leadership & Function Development

  • Define and drive the vision for Medical Information, including medical inquiry management globally for uniQure's products.
  • Build the Medical Information function, including strategy, systems, and processes.
  • Align Global Medical Information strategy with Medical Affairs objectives and enterprise goals.

Operational Excellence & Content Management

  • Oversee Medical Information systems, vendors, and processes to ensure quality, efficiency, scalability, and compliance.
  • Develop and maintain a medical information database, standard response documents (SRDs), FAQs, and AMCP dossiers.
  • Oversee medical inquiries from healthcare professionals, caregivers, patients, and internal teams.
  • Monitor emerging scientific data and competitor activity to keep medical information materials current.
  • Track departmental KPIs to assess system performance and implement improvements.

Cross-Functional Collaboration & Insights

  • Collaborate with Medical Affairs, Clinical Development, Regulatory, Legal, Commercial, Pharmacovigilance, Market Access and Patient Advocacy teams.
  • Generate actionable insights from medical inquiries to inform product development, medical strategy, and commercial and market access activities.
  • Train internal stakeholders, including MSLs and commercial teams, on medical information policies and best practices.

Compliance & Quality Assurance

  • Ensure compliance with global regulations (FDA, EMA, PhRMA, ICMJE) and industry standards.
  • Maintain audit-ready processes aligned with medical review standards.

Leadership

  • Foster a culture of ONEuniQure, focused on passion, accountability, tenacity and integrity.
  • Manage budgets and forecast departmental spend.

Qualifications & Skills

  • Advanced degree (PharmD, MD, PhD, or equivalent) in life sciences field required.
  • Minimum 10+ years Medical Information experience in biotech/pharmaceutical industry.
  • 5+ years leadership experience.
  • Experience with product launches, particularly rare diseases or specialty therapeutics preferred.
  • Rare disease, or neurology experience strongly preferred and gene therapy experience a plus.
  • Strong knowledge of global regulatory guidelines governing medical information activities.
  • Excellent communication and presentation skills with ability to translate complex scientific data for diverse audiences.
  • Proficiency in medical literature evaluation, database management, and medical information systems.
  • Strong analytical skills and ability to synthesize data into meaningful communications.