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Executive Director, Global Health Economics & Outcomes Research

Company: Humacyte
Location: Durham
Posted on: January 15, 2022

Job Description:

Humacyte, Inc. is proud to be a vaccinated workplace where all employees are expected to be fully vaccinated against COVID-19 . Proof of full vaccination is required before beginning work. Humacyte will provide accommodations as required by law.

Humacyte is a late stage clinical biotech company developing a first in class tissue engineered human acellular blood vessel (HAV) to address multiple unmet needs in vascular repair and reconstruction. Humacyte's manufacturing process combines advanced upstream bioprocessing technology and novel, automated production systems.

Position Background:
The Executive Director, Global Health Economics & Outcomes Research (HEOR) is committed to scientific excellence and the generation of evidence to support value propositions to position Humacyte portfolio for commercial success. The Executive Director Global HEOR will lead the strategy and tactical efforts to address both US & global health economics-related drivers and barriers to market access for all pipeline assets. This position will assess evidence needs, propose inclusion of clinical trial endpoints and inform on other aspects of clinical trial design, and lead relevant strategic evidence generation, including analyses of data from both primary and secondary sources, and partner with Commercial on the development of the product value propositions and messaging. This position will support Humacyte innovative pipeline programs. This role will require cross-functional collaboration across departments such as Clinical Development, Regulatory, Commercial, and multiple other functions.

This position reports to Chief Commercial Officer

Remote Work Designation: Remote

Primary Responsibilities:
Develop and maintain a thorough understanding of the health outcomes and health economics associated with Humacyte's products and competing alternatives
Design and execute cost-effectiveness and cost utility studies, retrospective and Real-World Evidence database analyses, patient-reported outcomes research, and decision-analytic modeling to develop economic utility evidence for payer coverage
In collaboration with the Market Access Lead, design and develop evidence-based health economic models to support US & global strategies and local payer needs.
Design and conduct studies to elucidate burden of illness, budget impact, and cost-effectiveness in disease segments of interest for Humacyte products and aligned with corporate business objectives
Review literature and develop dossiers, burden of illness reports, etc. for dissemination both internally within Humacyte and with external payers
Serve as the subject-matter expert in Health Economics and Outcomes Research and in that role as part of the MLR review process
Ensure appropriate economic and outcomes endpoints are integrated into clinical trials
Prioritize model data requirements which may be addressed through clinical trials and evidence generation activities and work with clinical team to provide input on endpoint structure of clinical trials
Work closely with computational scientists, statisticians, and payer specialists
Assist in the design, execution, analysis and publication of HEOR strategies and tactics to support the pricing and value propositions of the pipeline of products
Analyze secondary data, including insurance claims, electronic medical records, patient surveys, and disease registries
Engage with global health economics opinion leaders and external clinical advisors; seek their guidance, validation, and support including through leading Advisory Boards
Partner with Medical Affairs and Clinical Development colleagues to prepare conference presentations, manuscripts, and other communications
Build/adapt content and data for submission to health insurers and global payment authorities
Support development of innovative approaches to evidence generation that meet payer needs and integrate these with the needs of other customers
Accountable for the development and execution of indication specific HEOR strategic plans, tactical plans, budget planning and integration of those plans into the medical and brand plans
Other duties, as assigned

General Competencies:
Possess a positive attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Strong communication (verbal and written) and organizational skills
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Detail-oriented, self-motivated and scientifically driven
Motivated and organized critical thinker with solid interpersonal and communication skills
Strong analytical and problem-solving skills
Demonstrated ability to work in a cross functional team
Routinely communicate findings and information to other team members; transparency and knowledge sharing is expected and practiced
Must be able to work as needed to meet tight deadlines and at peak periods

Special Competencies:
Develop meaningful cross-functional relationships, work effectively with colleagues from all parts of the organization, and respond to team needs effectively and efficiently.
Use rigorous logic and analytical methods to solve difficult problems, thrive in ambiguity and act with incomplete information, be self-motivated and advance projects with minimal supervision
Ability to review clinical and health economic literature, including disease state information, clinical trial design and results, and pharmacoeconomic studies, in order to understand implications for value to payers
Ability to drive results in a highly fluid, interactive, matrixed environment and build strong, successful cross-functional partnerships
Demonstrated ability to bring structure to vaguely defined problems, pragmatically scope problem solving approach, and manage execution
Demonstrated ability to think and plan strategically, identify strategic options and trade-offs; strong analytical skills

QUALIFICATIONS:
PharmD, Masters, MD, or PhD in Health Economics, Public Health, Outcomes Research, Health Services Research, or other related field, required
Experience will be considered in lieu of education
Biological sciences or clinical background, required
8-10 years of HEOR experience, including both pre and post product launch. Global experience required. Previous experience working in the consulting, academic, or payer setting may be considered.
Experience developing global value dossiers, health economic models (Budget Impact and Cost-Benefit), patient-reported outcome strategy (regulatory and analytical), HTA value assessment, and observational research methods required
Knowledge of the evolving payer landscape and payer evidence requirements in the US and globally
Experience with both inpatient and outpatient procedures
5+ years biologic, Regenerative Medicine, Device experience highly preferred
Familiarity with health claims data
Track record of peer-reviewed publications

Perks:
Stock Options
401k Plan with Matching
Medical, Vision and Dental Plans
Long Term/Short Term Disability
Life Insurance
23 Days Paid Time Off (PTO)
11 Paid Holidays
Paid Parental Leave Policies

**Please note, Humacyte does not provide sponsorship at this time.**

Keywords: Humacyte, Durham , Executive Director, Global Health Economics & Outcomes Research, Healthcare , Durham, North Carolina

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