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Senior Director, Real World Evidence

Semma Therapeutics

Semma Therapeutics

Sales & Business Development
Boston, MA, USA
Posted on Friday, June 7, 2024

Job Description

General Summary:

Reporting to the Global Head of the Real World Evidence, the Senior Director of Real World Evidence is responsible for establishing rigorous assessment of real world data to assess the natural history of disease and real world outcomes for the Vertex early development and clinical portfolio. The Senior Director of RWE will shape and influence all aspects of global observational research, particularly the strategic execution of observational research to inform development and regulatory strategies within their disease portfolios. These analyses inform the real world utilization and outcomes of Vertex therapeutics to inform regulators, clinicians, payers, policy makers, patient groups and internal decision making.

Key Duties and Responsibilities:

  • First line manager for RWE disease area direct reports across the portfolio
  • Leads the assessment and prioritization of research gaps and objectives across key partners and disease areas to determine epidemiology/observational research strategy, research objectives and tactical plans for cross disease area projects, as well as appropriate differentiation strategies
  • Excellent communication skills, advanced multi-stakeholder experience, comprehensive understanding of Vertex business and development goals, and a highly-evolved capability to translate RWE strategic narratives to diverse audiences
  • Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research
  • Cross-functional collaboration with Global Clinical Development to provide strategic and tactical leadership for developing RWD historical controls or contextualization data
  • Continually drive towards testing and implementing innovative methods for conducting RWE studies and alignment with current regulatory guidance for RWE studies
  • Identify opportunities for efficient development of innovative research initiatives and application across disease areas
  • Experienced in the strategic planning, execution, and publication of multiple RWE observational studies
  • Oversee RWE study leads’ compliance with study conduct and tracking according to standard operating processes and working documents
  • Proactively identify opportunities and initiate process improvements for optimal quality, cost, speed, innovation, efficiency and effectiveness
  • Partners in multiple projects to ensure RWE capabilities are utilized, both cross-functionally and internally
  • Oversee performance metrics and dashboards for RWE projects across the portfolio
  • Assess real world data assets and establish real world data generation plans, including data licenses and data platforms
  • Initiates key research collaborations to fulfill prioritized research gaps
  • Advanced subject matter expertise of RWD sources and their best fit for research

Knowledge and Skills:

Education and Experience:

  • PhD in epidemiology, biostatistics, health economics and outcomes research, or similar required
  • Formal graduate training in Epidemiology/Health Services Research required
  • Minimum 12 years-experience in observational research study management AND data analytics, either within the life sciences/biopharmaceutical industry or with an observational research consulting firm
  • Recent team supervisory / management

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.