Director, Health Economics & Value Access (HEVA) Asset Lead

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 6366 

 

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We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

Director, Health Economics & Value Access (HEVA) Asset Lead 

 

Responsibilities

• A solid understanding and experience of Clinical Outcomes Assessment (COA) strategy to support the value of pipeline R&D assets including:
  • Leading Patient Reported Outcomes (PRO)-related activities for assigned compounds and disease areas in collaboration with the compound development and clinical teams and commercial functions.
  • Developing strategies for PRO evaluation of pharmaceutical compounds for product approval, quantifying value, and supporting market access.
  • Leading the development of PRO sections of the protocol/statistical analysis plan in conjunction with the study statisticians before database lock and interpretation of PRO clinical trial results
  • Leading the development of relevant sections of documentation and communication for regulatory agencies and HTA agencies to provide the necessary evidence in support of submission activities.
  • Responsible for PRO publication plan including the development of abstracts and manuscripts on PRO results from clinical and other studies.
  • Be the subject matter expert for PRO/COA. Educate and promote the importance of timely and relevant COA measurements within the organization across the diverse clinical programs.
  • A solid understanding of Real-World Evidence (RWE) research designs, Cost Effectiveness Analysis/Budget Impact Analysis (CEA/BIA) models, Systematic Literature Reviews (SLR), Indirect treatment comparison (network meta-analysis (NMA), matching adjusted indirect comparisons, etc.) with ability to critically evaluate-improve study design and data sources used across various type of HEVA research.
  • Training field teams-US Market Access Account Management/ Medical Science Liaisons and HEVA Field based teams current and relevant HCEI developed by the organization
  • Deep knowledge of/exposure to US/Global Pharmaceutical launch experience, specifically
    • Pre-Approval Dossier and Pre-Approval Information Exchange with population health decision makers (FDA Guidance)
    • Launch models (CEA/BIA) and tools development
  • Good working knowledge of health care systems and health technology assessment guidelines and processes in relevant countries
  • Ability to understand assigned therapy areas and appropriately plan and deliver HEVA value evidence and payer/HTA tools for specific assets.
  • Serve as subject matter expert for cross-functional teams in the area of HEVA.

 

Qualifications

• Education Required:
  • Doctoral degree (PhD or PharmD, or MD) preferred in related field and experience conducting HEVA research (Related fields include Public Health-Health Policy & Management/Health Services Research/Epidemiology/Outcomes Research/Health Economics, Economics/Econometrics, Psychometrics, Statistics/Biostatistics, Pharmacoeconomics/Pharmacy Administration)
  • At least 3-5 years of relevant experience in pharmaceutical/biotechnology/academic/governmental agency OR a Master’s degree in Health Economics, Epidemiology, or related field, and at least 10 years of such relevant experience
• Experience
  • Strong working knowledge and application of the 2009 FDA "Guidance for Industry Patient-Reported Outcome Measures: Use in - Medical Product Development to Support Labeling Claims" and other relevant PRO and Patient-Focused Drug Development (PFDD) guidance and best practices is required.
  • Experience with identifying, recommending, and implementing preference-based PROs (e.g., EQ-5D, SF-36, PROMIS) for clinical development programs.
  • Experience with eCOA implementation preferred, including but not limited to eCOA vendor identification, qualification, and technical supervision. Assist clin ops team members in securing licenses and commissioning translations/adaptations for COA instruments in a timely manner.
  • Strong knowledge of