The posting
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
This role will lead Denali's global HEOR strategy for ex-US markets, generating and applying health economic and outcomes research evidence to secure timely and sustainable patient access. The role is accountable for the core global health economic model and cost-effectiveness analysis and the real-world evidence required to support the EU Joint Clinical Assessment (JCA), national health technology assessment (HTA), and reimbursement negotiations. This role partners closely with International Market Access, US Market Access, Clinical Development, Regulatory, Biometrics, Medical Affairs, and Commercial colleagues to align evidence generation with clinical development plans, launch sequencing, and access objectives, and represents Denali's outcomes science expertise in HTA body and payer scientific engagements. Responsibilities are expected to extend to additional pipeline molecules as they advance through late-stage development into launch. The successful candidate will combine deep expertise in health economics and outcomes research across European and other international markets with experience supporting the introduction of innovative therapies in a global biotech environment, and will bring strong communication skills, sound methodological judgement, and the ability to operate effectively in a fast-paced, hands-on environment.
Responsibilities
- Define and lead the global HEOR strategy for ex-US markets, ensuring alignment with market access, regulatory, and launch objectives.
- Lead development of the core global health economic model and cost-effectiveness analysis, including model design, economic methodology, validation, and technical documentation.
- Partner with International Market access to develop and maintain the global value dossier and its underlying evidence base, including systematic literature reviews and indirect treatment comparisons.
- Lead the HEOR deliverables supporting the EU Joint Clinical Assessment, including PICO-driven evidence planning and comparative effectiveness analyses, in partnership with Regulatory, Biometrics, and Clinical Development.
- Serve as the global HEOR partner to International Market Access, providing the global model, methods guidance, and scientific review that support country-specific adaptation and country-level JCA and HTA deliverables.
- Design and oversee real-world evidence and non-interventional studies — including registries, natural history and external control analyses, burden of illness, treatment patterns, and resource use — from data source selection, feasibility assessment, and data access and governance through protocol development and publication, addressing evidence requirements arising in HTA appraisal and reimbursement negotiations.
- Support early engagement with HTA bodies and payers (e.g. G-BA/IQWiG Germany, HAS France, NICE UK) to inform evidence generation strategy and dossier development.
- Guide endpoint, patient-reported outcome, and utility data collection strategy within clinical development programs so that trials generate evidence acceptable to HTA bodies.
- Manage external HEOR vendors, budgets, and contracts, ensuring quality and timely delivery across competing priorities.
- Contribute to the development of global HEOR standards and ways of working, and provide technical guidance and mentorship to colleagues as the function scales.
Qualifications and Experience
- Graduate degree in health economics, epidemiology, health services research, or another research-focused public health discipline (PhD preferred); 10+ years of HEOR experience with an MSc/MPH, or 8+ years with a PhD.
- Extensive experience leading HEOR evidence generation to support HTA submissions across multiple European and other international markets.
- Direct experience engaging with HTA organisations such as G-BA/IQWiG, HAS, NICE, ZIN, CADTH, and PBAC.
- Working knowledge of the EU HTA Regulation and the Joint Clinical Assessment process, including PICO scoping and its implications for global evidence planning.
- Demonstrated ownership of global cost-effectiveness models and global value dossiers, with accountability for methodology and technical defensibility rather than vendor oversight alone.
- In-depth command of health economic modelling, evidence synthesis, patient-reported outcomes, statistics, and observational study design, implementation, analysis, and interpretation.
- Strong project management capability, including contracting, budgeting, and vendor management, with the ability to manage competing deadlines and shifting priorities.
- Demonstrated ability to influence senior stakeholders across clinical, medical, and commercial functions, and to operate effectively within a global matrix across multiple time zones.
- Business fluency in English.
Preferred
- Experience in neurology, neurodegeneration, rare disease, or orphan conditions.
Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a pension, medical stipend, equity and a broad range of other benefits.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
