Senior Director, Global Health Economics and Outcomes Research

Location
Boston, MA
Posted
Mar 01, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.

The Senior Director of Global Health Economics and Outcomes Research (HEOR) is a key strategic leader within the Global Medical Affairs (GMA) organization and will serve as a core member of the Medical Affairs Leadership Team (MALT). This individual will be responsible for build and oversight of the HEOR function, and for the establishment of global HEOR strategies and tactics to support regulatory approval, labeling, publications, market access, pricing, and reimbursement for Arena’s pipeline products. He/she will work cross-functionally with Market Access and other functions, including Clinical Development and Biostatistics, and will ensure that HEOR strategies and tactics align with the overarching product plan and value story.
 

What you’ll dive into

  • Build Global Health Economics & Outcomes Research (HEOR) function in Boston and Zug, Switzerland
  • Develop and implement clinical outcome assessment (COA) measurement plans across clinical programs to support product approval, labeling, patient access, and differentiation
  • Ensure COAs are appropriately implemented in clinical trials, including reviewing relevant clinical protocol sections
  • Provide technical expertise in the analysis, reporting and dissemination of COA data
  • Produce COA/PRO evidence dossiers for regulatory submissions (e.g. FDA, EMA); advise on and contribute to COA/PRO sections of regulatory documents, including briefing documents and submissions
  • Interact with regulatory agencies (e.g. FDA, EMA) regarding COA endpoints
  • Prepare and submit publications presenting COA data
  • Maintain awareness of scientific and regulatory developments within COA area and communicate information internally
  • Identify and maintain successful research relationships with HEOR key opinion leaders and thought leaders
  • Work with GMA leadership to ensure adequate budget, FTE needs and integration of HEOR activities into integrated product plans
  • Conduct network meta analyses and create economic models (budget impact and costs effectiveness), EMR, claims analyses and observational research studies/analyses, post-hoc clinical trial analyses, development, validation and analyses of clinical outcome assessment measures and data
  • Deliver comparative effectiveness models and dossiers to demonstrate the additional therapeutic value of Arena’s products (as applicable)
  • Work collaboratively with cross functional team to plan and execute subgroup analyses of clinical data
  • Provide evidence-based, scientific support of local submissions and presentations to health technology appraisal (HTA), reimbursement and/or pricing authorities
  • Summarize and interpret evidence and provide strategic support for product lifecycle continuum and identify unmet needs for product differentiation

What we expect

  • Advanced graduate degree (Ph.D., MS, or MD, PharmD., B.Pharm with Master’s degree) in HEOR-related field (e.g. social sciences, psychology, healthcare/data analytics, health services research, public health, epidemiology)
  • 7+ years pharma (or consulting experience)
  • Significant experience with both drug development and marketed products
  • Knowledge of diverse research methods including cost-effectiveness/budget impact modeling, comparative effectiveness, patient reported outcomes, real-world evidence including database analyses (prospective and retrospective), epidemiology, and statistics/psychometrics
  • Strong technical expertise in design and implementation of COA/PRO measurements in clinical trials, including analysis and reporting of COA/PRO data
  • Strong publication track record in COA/PRO area
  • Experience corresponding with regulatory agencies (e.g. FDA, EMA) regarding COA/PRO issues, including attending and presenting at regulatory meetings
  • Significant experience in or with a variety of US payer segments, including but not limited to: health plans, PBMs, providers, commercial, and government
  • Experience with HTA submissions and reimbursement in Europe
  • Results oriented and excellent analytic and collaboration skills combined with robust project management capabilities
  • Ability to travel 20%-40% domestic and international

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance
  • Matching 401k retirement plan
  • Paid time off and holidays
  • Company celebrations

Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at jobs@arenapharm.com.