Director, HTA, Value & Evidence (HV&E) - Rare Disease

What You Will Achieve

• Lead the development of the evidence generation strategy to support the value of Hympavzi (marstacimab), in close partnership with the cross-functional matrix team (e.g., medical, commercial, access strategy/pricing, statistics, clinical).
• Lead the coordination of input from local country/regional teams on evidence needs and ensure that the input is appropriately incorporated into the evidence strategy to support global market access needs at launch and through lifecycle.
• Lead the design and execution of global HEOR studies (e.g., network meta-analyses, non-interventional studies, economic models) from concept through publication.
• Lead the timely development of launch deliverables including value & evidence strategy, global value dossiers/AMCP/JCA dossiers, systematic literature reviews, economic models, and innovative tools to successfully support reimbursement and access requirements in partnership with the regions/countries.
• Develop patient-reported outcomes strategy and incorporate humanistic and economic endpoints into clinical trials across all phases of product development to build comprehensive trial-based evidence aligned with overall asset strategy and to ensure global reimbursement and access requirements.
• Provide strategic input into clinical trial designs (eg, patient populations, comparators, endpoints) and analysis to enable successful negotiations, reimbursement, and appropriate patient access with global payer and regulatory decision makers.
• Partner with internal stakeholders to ensure appropriate customer facing dissemination of HEOR materials per regulatory guidance and internal SOPs.
• Develop strategic partnerships and research collaborations with key external experts, healthcare policy makers, payers, and various academic and community oncology settings to support asset strategies.

Here Is What You Need (Basic Qualifications)

• Graduate degree (e.g. MSc, MPH, PhD, DrPH)
• 7+ years of experience with MSc/MPH/MBA degree; 5+ years with PharmD/PhD/DrPH in HEOR or relevant related fields (health economics, epidemiology, health services research, or other research-focused public health field)
• Expertise in HEOR strategy, evidence development, fundamental health services research methods and tools, including health economic modeling, patient-reported outcomes, statistics, and real-world evidence studies including technical and methodological aspects of registries and observational study design, implementation, analysis and interpretation.
• Capable of independently managing complex non-interventional study projects
• Knowledge and understanding of drug development process
• Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers
• Excellent oral and written English communication skills
• Demonstrated ability to assess anticipated value for projects/programs to ensure alignment to business priorities and prioritize accordingly
• An “execution mindset” focused on getting things done quickly and simply
• Strong project management abilities (contracting, budgeting, vendor management) essential.
• Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities and expertise in stakeholder engagement
• Leadership in cross-functional teams (e.g. influence medical, clinical, and commercial teams constructively and without conflict); strategic thinking, and ability to guide junior team members
• Skilled in functioning within a matrix organization
• Organized and detail oriented with the ability to anticipate needs and to work proactively to prioritize & address/resolve
• Change oriented, comfortable responding to unexpected demands with tight timelines

Preferred Qualifications

• Knowledge and experience in the Rare Disease therapeutical area
• Experience with HTA organizations such as NICE, CADTH, PBAC, ICER and other HTA groups
• Knowledge of industry trends (e.g. IPAY, EU HTA Regulation)
• Demonstrated publication history in peer reviewed journals
• Experience in the biotech/pharmaceutical industry
• Experience in supporting a global launch