This is an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.
This role of Director Global Health Economics and Outcomes Research (HEOR) will specialize in Outcomes Research. He/she is a key strategic leader within HEOR function in the Global Medical Affairs (GMA) at Arena Pharmaceuticals and will serve as a core member of the Medical Value Team (MVT) and Commercial Medical Team (CMT). In collaboration with market access, commercial, clinical development team, and various functional team within GMA organization, the Director of Global Health Economics and Outcomes Research (HEOR) will lead the development of global HEOR evidence generation plan and execute tactics to support regulatory approval, labeling, publications, market access, pricing, and reimbursement of Arena's pipeline products. It is also important to ensure that HEOR evidence generation plan and tactics align with the overarching product plan and value story. The successful individual will seamlessly integrate him/herself in a highly matrix and fast paced organization where close collaboration with various Arena Pharmaceuticals team members in both San Diego and Switzerland offices is expected.
What you'll dive into
To lead the development of outcomes research evidence generation strategy and the execution of various HEOR projects to support product strategy and value propositions of Arena's assets which include but not limited to:
Conduct observational studies (i.e., epidemiological studies, burden of illness, outcomes research).
Develop real world evidence generation strategies and lead its execution (i.e., treatment patterns, real world effectiveness, epidemiological studies, prospective observational studies such as registries, retrospective chart review, PRO instrument developments, cross sectional surveys, etc).
Develop and validate new Patient Reported Outcomes measures as appropriate, for inclusion across clinical trials, registries, and prospective real-world studies.
Incorporate humanistic and economic endpoints into Arena's clinical trials programs across all phases of product development to build comprehensive trial-based evidence in line with overall medical strategy & market access targets for the assets.
Provide strategic input in the selection of relevant patient population and comparators within clinical trials to enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers.
Assess, synthesize, and interpret relevant literature and communicate findings to internal and external stakeholders.
Lead or contribute to the development of economic models to meet the needs and requirement of various HTA agencies globally (ie., cost-effectiveness (CE) model, cost-benefit analysis, cost-consequence analysis and budget impact models (BIM).
To provide key methodological expertise within HEOR and cross functionally, on various scientific and methodological issues pertaining to epidemiology, outcomes research, research study designs, and methods for handling bias in real world evidence generation activities. The successful candidate will also function as a scientific and methodological and strategic resource for HEOR team and cross functional team within Arena Pharmaceuticals.
Facilitate, execute and manage research collaboration projects with external collaborators (i.e., IDNs, ICOs, MCOs, Specialty pharmacies, 3rd party payers) to support Arena's strategic visions and ensure high quality deliverables and timelines are met.
Create and maintain global value dossier (GVD) and its adaptations to local evidence dossier, evidence blue-prints, and innovative tools needed to support value proposition of Arena's assets.
Lead the coordination of inputs from local country affiliates on evidence needs and ensure that the input is appropriately incorporated to support global market access needs.
Lead and contribute to the reimbursement and HTA submission by developing a sound economic argument that will be the main content of economic sections in various reimbursement support dossier. Lead the development of responses to inquiries generated by various HTA agencies regarding the value of Arena's products.
Generate peer-reviewed publications to communicate study findings in scientific channels, so that the value story for Arena assets is in alignment with the product publication strategy. Effectively and professionally, represent Arena in various scientific meetings to present posters, podium presentation, symposia, workshops and become the primary driver for development and dissemination of various HEOR evidence to support Arena product value (ie., abstracts, posters, and manuscripts).
What we expect
D, M.D, D.O, R.N, N.P, Dr.PH), and Master's degree (Msc, ScD) in Health Economics, Pharmacoeconomics, decision sciences, health services research, pharmacy administration, psychology, healthcare/data analytics or related fields with 6+ of experience in pharmaceutical industry or PhD in Health Economics, Pharmacoeconomics, decision sciences, or health services research with at least 4+ years experience
Demonstrated understanding and highly experienced in fundamental health services research methods and tools including familiarity with:
Outcomes research, and real world evidence generation strategies and execution
Prospective and retrospective data analysis
Excellent methodological knowledge in multivariate modeling, econometrics, experimental study designs, and experience in conducting observational studies (i.e., retrospective claims database analysis, retrospective chart review, prospective observational studies).
Experience in development of global value dossier (GVD), and AMCP dossiers in the USA.
Experience in HEOR role globally, and experience in interfacing with external scientific bodies & preference for hands on experience in interacting with reimbursement agencies in US and/or Ex-US.
Knowledge and experience in immunology and inflammation, gastroenterology, dermatology, and cardiovascular is preferred but not required
Excellent knowledge and awareness in systematic review of evidence is also essential (i.e., deep understanding of bayesian methodology to conduct Mixed Treatment Comparison (MTC) network meta analysis, bucher's method of indirect comparison, Match Adjusted Indirect Comparison (MAIC) etc.).
Appropriate awareness for the intricacies of global drug development process as well as the various regulatory requirements in various jurisdictions.
Excellent knowledge and/ or experience in PRO instrument development according to FDA PRO guidance, and good understanding in psychometric testing, Item Response Theory, and various instrumental validation methodologies.
Strong leadership skills, , negotiation skills, ability to influence without authority, ability to work cross-functionally, excellent work ethics, and a self-starter who is motivated and able to work independently
Ability to travel 20% to 40% domestic and internationally
What you'll get
To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
Opportunities to learn and contribute creative solutions
Comprehensive health insurance
Matching 401k retirement plan
Paid time off and holidays
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at firstname.lastname@example.org.