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

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

 

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
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 development, psychometric evaluation, and selection of PROs preferred.
    • Experience with developing meeting requests/briefing books to support FDA COA Type C meetings.
    • Experience with the development of sections 5.3.5.3 (Clinical Study Reports), 2.5 (Clinical Overview), and Summary of Clinical Efficacy (2.7.3) for inclusion as Patient Experience Data for NDA Module 2 submission preferred to support Consistent with FDA label communications.
    • Regulatory understanding and experience in negotiating PRO label claims is strongly preferred.
    • A track record of peer-reviewed scientific publications demonstrating expertise in HEVA across Real World Evidence, Cost Effectiveness Analysis/Budget Impact Analysis models, PRO development and or SLR/NMA.
    • Successfully developed/has a deep knowledge of/exposure to US FDAMA 114 compliant HEVA tools for population health decision makers/Health Care Economic Information (HCEI)
    • Experience with developing strategic responses to support the value of asset(s) under ICER Unsupported Price Increase review
    • Excellent communication skills, with experience presenting HEVA research to payers and/or population health decision-makers

 


 

Benefits for you

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

 

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Cambridge Erie Street. Apply now for your preferred job and location through our careers site.


*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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