Director, Real World Evidence (HEOR)

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The Director, Real World Evidence (RWE), HEOR, will ensure an enterprise-wide strategy and approach to RWE is realized across BioCryst. The Director, RWE, HEOR, will design and execute strategically focused and innovative RWE to support optimization of product registration, access & reimbursement, and clinical practice. S/He will provide global RWE support across BioCryst products (marketed and pipeline) and cultivate strong internal partnerships with clinical development, regulatory, medical, and commercial teams to enable effective cross-functional collaboration. In addition, the Director will represent BioCryst externally and assume a leadership role in collaborations with external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups). S/He serves as a subject matter expert within HEOR and BioCryst to drive the adoption/uptake of standards and best practices for RWE. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Co-chairs the cross-functional Global Evidence Teams (GETs) for BioCryst assets to ensure an enterprise-wide RWE approach is established to address customers’ demands for “value”
• Ensures alignment of RWE product strategy and studies across functions and communicates wholistic view of RWE to relevant governance teams
• Responsible for execution of global RWE generation and external stakeholder engagement strategies for HEOR that encompasses innovative research aligned with overall product strategy
• Leads management of HEOR projects to ensure timely execution of RWE research to characterize disease burden, unmet needs, treatment patterns, and outcomes (e.g., effectiveness, safety, utilization, costs)
• Leads/contributes to the integration of RWE into clinical development programs to help inform portfolio decisions and optimize study design, site selection, & patient recruitment in clinical trials
• Leads/contributes to strategy and development of RWE for regulatory filings, reimbursement submissions, and pricing discussions (e.g., value-based contracts / pay-for-performance) to demonstrate the value of BioCryst’s products across key markets
• Supports the development of strategic RWE communication plans that includes presentation of research at congresses & peer-review journal and proactive engagement with providers and payers to support reimbursement, access, adoption, and sustained use of BioCryst’s products
• Serves as internal subject matter expert on RWE data sources, methodologies, and applications while also ensuring the scientific integrity of conducted RWE research (e.g., study designs, protocols, results)
• Leads/contributes to above-brand RWE research collaborations with providers, health systems (e.g., IDNs), and payers
• Develops and delivers standards/best practices and educational resources for RWE to drive the integration of RWE across the organization
• Grows team and manages headcounts as required

EXPERIENCE & QUALIFICATIONS:

• Advanced degree (e.g., PhD, MD, ScD, PharmD) in related discipline with a minimum of ten (10) years of experience; or a Master's degree (e.g., MSc, MPH) with a minimum of twelve (12) years of relevant, post-graduate experience
• Experience in the life science industry required; strong preference for pharmaceutical/biotech experience; experience in a matrix organization and rare disease is preferred
• Experience with different applications of RWE, including in support of early-stage clinical development, regulatory approvals, and payer/HTA/provider engagements.
• Knowledge of global regulatory & HTA requirements for RWE
• Demonstrated ability in evaluation & development of RWE from conceptualization through application
• Experience leading the design and conduct of observational research, including protocol, statistical analysis plan, and study report development
• In-depth knowledge of currently available secondary data sources in and outside of the US
• Experience leading secondary data analysis, including medical claims, electronic medical records, chart reviews, and registries.
• Ability to effectively interpret and communicate research results to internal and external audiences
• Excellent interpersonal skills with an ability to leverage deep expertise to understand, respond and influence effectively across multiple internal and external customers; ability to facilitate consensus when differences of opinion exist
• Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations
• Demonstrated ability to manage multiple priorities in rapidly changing environment
• Excellent written and verbal communication skills
• Excellent project management skills

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.