Senior Manager, Health Economics & Outcomes Research

New Jersey, US; Cambridge, US; Gaithersburg, US   |   full time   |   Job ID: 8592 

Responsibilities:

• Working knowledge of Clinical Outcomes Assessment (COA) activities to support the value of pipeline R&D assets including:
  • Leading/supporting COA activities with HEOR 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 HEOR 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 HEOR research.
  • Lead/supporting relevant RWE activities (claims database, registries, EMR) to meet asset-specific evidence needs  
  • Lead/supporting global epidemiology targeted literature reviews
• Communicate findings in relevant regulatory grade documents (i.e., FDA briefing books, US Diversity Action Plan, Pediatric Investigation Plan)
• Knowledge of systematic Literature Reviews and Indirect treatment comparisons methodologies is desirable.
• Will provide operational support for all ongoing and planned HEOR activities, including but not limited to:
  • Manage the GMA-HEOR Teams folder structure/access/documents.
  • Assist in the development, documentation (and update) and training of HEOR 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/SMPC research, development of slides, input into critical scientific/regulatory documents.
  • Publication support for all HEOR 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 HEOR work products via VEEVA Medical/Promotional review or similar systems.
  • Provide/assist in training and educating Field Teams on HEOR 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 HEOR value evidence and payer/HTA tools for specific assets.
• As needed, serve as subject matter expert for cross-functional teams in the areas of HEOR.

Qualifications:

Education Required:

• MS required, Doctoral degree (PhD/PharmD/MD) preferred in related field and experience conducting HEOR research (Related fields including: 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 HEOR.
• Excellent communication skills.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.

Apply now - We look forward to your application!

Apply for our New Jersey, US; Cambridge, US; Gaithersburg, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter.