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Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Real World Evidence Associate Director

Biology & BiotechConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • Applied knowledge of relevant real-world evidence regulatory agency guidance and position papers, including opportunities to use real-world evidence to inform regulatory decision-making.
  • Demonstrated ability to design and execute observational research.
  • Strong and clear interpersonal communication, presentation, and study management skills.
  • Ability to communicate detailed observational study results clearly and in non-technical language to internal cross-functional teams while maintaining the integrity of key findings.
  • Ability to work collaboratively in a constantly changing, diverse, and matrix environment.
  • A master's degree or Master of Public Health in epidemiology, biostatistics, health economics and outcomes research, or a similar field is required.
  • Formal graduate training in epidemiology or health services research is required.
  • At least five years of experience working in observational research within the life sciences industry or a relevant academic, government, or consulting environment.
  • At least three years of experience working in real-world evidence and/or epidemiology at a biopharmaceutical company.

Responsibilities

  • Independently lead focused or targeted epidemiology research in specific disease areas, including natural history of disease for business development and early development indications.
  • Lead data-sourcing strategy for early development and early clinical indications to support natural history of disease requirements for regulators, payers, and clinicians.
  • Lead and execute evaluations of available registries and other data sources related to natural history and evidence supporting clinical endpoints and inclusion/exclusion criteria.
  • Determine potential use of real-world evidence historical controls within clinical development programs and assess the feasibility of obtaining the data required for historical controls.
  • Lead execution of approved research tactics within assigned indications.
  • Develop draft protocol concepts and related materials for review and approval by internal scientific review boards.
  • Work with stakeholders to align real-world evidence research study tactics with functional and disease program goals.
  • Contribute to development of performance metrics and dashboards for real-world evidence projects.
  • Represent real-world evidence on relevant GMDA sub-teams, program teams, or disease strategy teams where related studies are discussed.
  • Represent real-world evidence in cross-functional collaborations and working groups for pipeline products.
  • Use oral communication skills and understanding of Vertex strategies to promote and translate real-world data and real-world evidence methods and activities across the company.
  • Support and facilitate external research collaborations with key academic partners, consortia, and data vendors.
  • Support development of cross-functional evidence-generation planning.
  • Provide leadership and mentorship within real-world evidence.
  • Contribute to the company publications strategy by developing conference abstracts, presentations, and peer-reviewed manuscripts based on real-world evidence study findings.

Desired Qualifications

  • A PhD is preferred.

About the Company

Vertex Pharmaceuticals

Develops therapies for serious genetic diseases

Vertex Pharmaceuticals develops medicines for serious diseases, with a focus on cystic fibrosis. It conducts extensive research and partners with other biotech firms to discover and develop new therapies, including ex vivo engineered cell treatments. Its products, such as ivacaftor, treat cystic fibrosis and other therapies undergo clinical testing to expand the pipeline. Revenue comes from selling approved drugs and from licensing and collaboration agreements. The company distinguishes itself through deep R&D investment, strategic partnerships, and a global reach aimed at addressing unmet medical needs. The overall goal is to bring effective new drugs to patients worldwide and improve outcomes and quality of life.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boston, MA
Founded
1989

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