The posting
Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
The primary purpose of this role is to develop and communicate the evidence that establishes product value — including health economic evidence and real-world evidence (RWE)— and to disseminate that evidence in support of healthcare decision-making. The role is global in nature with a primary focus initially on leading development and dissemination of evidence for US stakeholders, while working on global evidence deliverables in a supportive role. This role requires effective cross-functional collaboration and coordination with Clinical Development, Medical Affairs, Biometrics, Marketing, US & International Market Access, and field teams to maintain consistency of value evidence across markets. The successful candidate will combine rigorous methodological expertise across health economics, outcomes research, and real-world evidence with a demonstrated ability to execute end to end, from strategy development to tactical execution through publication, and will bring strong communication and ability to drive alignment in a fast-paced, matrixed environment.
Responsibilities
- Develop and execute HEOR strategic plans for assigned programs, with primary accountability for US evidence needs, reflecting the input of key stakeholders and aligned with commercial, clinical, medical, and market access plans.
- Design and execute HEOR studies, including economic modeling, real-world evidence, clinical outcomes assessment, indirect treatment comparisons, and systematic literature reviews, to substantiate the product value proposition.
- Design and oversee real-world evidence studies using US claims, electronic health record, registry, and primary data sources, including data source selection, feasibility assessment, and data access and governance.
- Develop economic models and healthcare economic information (HCEI), and train field teams for effective and compliant communication with population-based decision makers.
- Provide input to the design of clinical development programs to ensure appropriate inclusion of design elements and endpoints relevant to payers, clinicians, and patients.
- Lead AMCP dossier development and synthesize health economic and outcomes evidence contributing to global value dossier development.
- Lead the HEOR dissemination strategy in alignment with the overall product communication strategy, including timely publication of abstracts and manuscripts and presentation at scientific congresses.
- Support selected ex-US evidence deliverables, and ensure coordination between US and ex-US evidence in line with the global evidence strategy
- Collaborate cross-functionally with market access, medical affairs, biometrics, commercial, operations, and clinical development functions to integrate HEOR plans within the broader strategic framework.
- Manage HEOR vendors and consultants, ensuring deliverables meet objectives, quality standards, and timelines.
Qualifications and Experience
- Advanced graduate degree (PhD preferred) in a relevant discipline such as health services research, health economics, epidemiology, or public health.
- Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 10 years and a Master’s degree; or a PhD with 7 years experience; or equivalent experience.
- Knowledge of US and global healthcare systems, US payer and global HTA evidence requirements, and clinical development sufficient to define product value propositions, identify evidence gaps, and formulate evidence generation and communication strategies.
- Demonstrated research capability in HEOR study design, analysis, and interpretation, with accountability for the scientific and technical rigor of HEOR deliverables.
- Experience leading economic modeling, evidence synthesis including systematic review and indirect treatment comparison, and observational study design using US real-world data sources.
- Experience developing AMCP dossiers and healthcare economic information for US population-based decision makers, including familiarity with the regulatory and compliance framework governing communication of such information.
- Proven track record of end-to-end project execution, from concept development through publication.
- Ability to execute HEOR projects independently with minimal guidance.
- Excellent communication, presentation, collaboration, and influencing skills across internal and external stakeholders in a multicultural environment.
Preferred
- Experience leading HEOR strategy development and execution in support of a product launch is highly preferred.
- Experience in outcomes research in rare disease and/or neurodegenerative therapeutic areas.
- Familiarity with ex-US HTA evidence requirements and experience contributing to global value dossier development.
Salary Range: $139,000.00 to $180,000.00 . 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 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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.
