Senior Manager, Health Economics & Value Access (HEVA) Asset Lead

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 6367

 

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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.


 

Senior Manager, Health Economics & Value Access (HEVA) Asset Lead 

 

As the Senior Manager of Health Economics and Value Access (HEVA) Lead, you will be responsible for developing compelling health economic value evidence across all aspects required for a successful Global Launch for a phenomenal oncology pipeline.
 

Responsibilities

  • Working knowledge of Clinical Outcomes Assessment (COA) activities to support the value of pipeline R&D assets including:
    • Leading/supporting COA activities with HEVA subject matter expert (SME) for assigned compounds and disease areas in collaboration with the clinical and commercial functions.
    • Leading the development of COA sections of the protocol/statistical analysis plan in conjunction with HEVA SME and study statisticians before database lock and interpretation of COA clinical trial results
    • Supporting 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 COA publication plan including the development of abstracts and manuscripts on COA results from clinical and other studies.
  • A solid understanding of Real-World Evidence (RWE) research designs and economic models (cost effectiveness analysis/budget impact analysis) with ability to critically evaluate-improve study design and data sources used across various type of HEVA research.
    • Knowledge of systematic Literature Reviews and Indirect treatment comparisons methodologies is desirable.
  • Will provide operational support for all ongoing and planned HEVA activities, including but not limited to:
    • Manage the GMA-HEVA Teams folder structure/access/documents.
    • Assist in the development, documentation (and update) and training of HEVA critical company processes.
    • HCP Contracting, Setup and invoice & payment tracking, Vendor on-boarding (CDA, MSA and Supplier Profile), Vendor contracting, accurate tracking and release of invoices. Other accounting activities.
    • Conducting Targeted Literature Reviews (TLRs), Clinical Trial and USPI/SMCP research, development of slides, input into critical scientific/regulatory documents.
    • Publication support for all HEVA congress and manuscripts in development: Author invites, Author reviews, Collation and Comment Reconciliation, internal Medical-Legal-Regulatory reviews-collation and comment reconciliation.
    • Submission and approval of Field tools containing HEVA work products via VEEVA Medical/Promotional review or similar systems.
    • Provide/assist in training and educating Field Teams on HEVA work products.
  • 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.
  • As needed, serve as subject matter expert for cross-functional teams in the areas of HEVA

 

Qualifications

  • Education Required:
    • MS required, Doctoral degree (PhD/PharmD/MD) preferred in related field and experience conducting HEOR research (Related fields includeing: Public Health-Health Policy & Management/Health Services Research/Epidemiology/Outcomes Research/Health Economics, Economics/Econometrics, Psychometrics, Statistics/Biostatistics, Pharmacoeconomics/Pharmacy Administration)
    • At least 2 years of relevant experience in pharmaceutical/biotechnology/academic/governmental agency OR Post-Doctoral Health Economics and Outcomes Research Fellowship OR a Master’s degree in related field, and at least 5 years of relevant experience
    • A pharmacy/medicine/clinical background is preferred.

 

  • Experience Required:
    • Strong working knowledge and application of the FDA Patient-Focused Drug Development (PFDD) guidance, other PRO guidance(s), and COA best practices is required.
    • Experience with identifying, recommending, and implementing preference-based PROs (e.g., EQ-5D, QLQ-C30, etc) for clinical development programs.
      • Experience with eCOA implementation preferred.
      • Assist Clinical Operations team in securing licenses and commissioning translations/adaptations for COA instruments in a timely manner.
    • A track record of peer-reviewed scientific publications demonstrating expertise in HEVA.
    • Excellent communication skills
    • Experience in Oncology therapeutic area is desirable.

 


 

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 StreetApply 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!