Sr. Director, Health Economics and Outcomes Research

Market Access Waltham, Massachusetts


Description

Position Summary:

The primary role of the Sr. Director, HEOR is to lead the Health Economics and Outcomes Research (HEOR) strategy and their tactical execution for pipeline products. In this role, the individual will ensure the successful implementation of HEOR tactics through appropriate research design, project management, analysis, interpretation and dissemination of HEOR evidence and communication of appropriate HEOR key value messages for APL-2 in clinical development, focusing primarily on Paroxysmal nocturnal hemoglobinuria (PNH) and Geographic Atrophy (GA) . This role requires the individual to collaborate cross-functionally with individuals and teams in Clinical Development, Clinical Operations, Medical Affairs, Marketing, and other allied functions in demonstrating and leveraging the HEOR value proposition of Apellis’ products.

Key Responsibilities Include:

  • Develop and lead HEOR strategy for PhII-PhIV clinical trial programs including design, PRO identification and development, appropriate endpoints, data collection methods, data analysis and interpretation through collaboration with Clinical Development and Commercial teams
  • Participate as an integral member of clinical development teams ensuring correct analyses for payers are being planned within the context of the Phase III study as well as alongside the clinical trial programs through real world evidence analyses and publication
  • Conceptualize, implement, and manage HEOR projects from inception to completion for all phases of research, including publication, dissemination, and presentation
  • Develop a comprehensive and compelling HEOR publication strategy, in alignment with the scientific communication strategy to appropriately disseminate the generated HEOR evidence
  • Design and oversee strategies to obtain regulatory approval of PRO (health-related quality of life) claims including engagement and negotiation with the FDA and COA teams
  • Conduct and communicate patient and caregiver qualitative research within the context of utilizing sound survey research principles
  • Finalize HEOR input into protocols, statistical analysis plans, and study reports for data collection and analysis for filing and pricing/reimbursement submissions 
  • Develop HEOR manuscripts from data obtained from clinical studies that included health economics and PRO components
  • Develop economic models and analysis to understand pricing thresholds and key value drivers to optimize the value proposition and defend price and access at launch
  • Develop health economic analyses or economic models to assess cost-effectiveness, clinical practice, and/or burden of illness using a combination data from internal clinical trials and external primary or secondary data sources
  • Design and conduct robust retrospective analyses to support burden of disease, treatment patterns, and total costs of care 
  • Contribute to the development of affiliate tools including value dossiers, models, and calculators for submission to reimbursement authorities and formulary committees
  • Develop and maintain external relationships with lead HEOR researchers, academia, and relevant decision-makers to keep abreast of key environmental changes related to policy reimbursement

Education, Registration & Certification:

  • Post-graduate degree – PhD or MD, PharmD, MS, MPH, MBA

Experience:

  • A minimum of 10 years of experience in health economics within a pharmaceutical or health organization
  • Strong methodological, quantitative and analytical skills combined with a sound understanding of how to successfully apply HEOR principles to support the enterprise
  • Ability to work with large retrospective databases including reimbursement claims databases, electronic medical records, and other data platforms

Skills, Knowledge & Abilities:

  • Creative thinker; ability to develop innovative solutions within a complicated pricing and reimbursement environment
  • Demonstrated ability to think strategically and make sound health economic and outcomes research decisions
  • Forward looking to build a meaningful footprint within the organization; ability to coach and mentor future direct reports or others within a matrix environment
  • Strong track-record of being results-driven and demonstrating clear accountability for achieving business success
  • Strong project management skills with oversight experience in both internal and external projects are necessary
  • Publication/presentation track record with experience in medical/scientific writing, internal/external educational training on interpretation of HEOR data and resulting tools, third party payor support and KOL development
  • Demonstrated understanding of legal and regulatory issues impacting HE/PRO labeling and promotional claims
  • Demonstrated understanding of the dynamics of the US and global health care systems and financing mechanisms
  • Strong presentation and interpersonal skills with demonstrated ability in participating and leading cross-functional teams, excellent skills in leading without authority, and negotiating and managing through influence

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

 

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.