Job Description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!

ASSOCIATE DIRECTOR/ DIRECTOR, HEALTH ECONOMICS AND OUTCOMES RESEARCH (HEOR) (EARLY STAGE PIPELINE)

The Associate Director/ Director of Health Economics and Outcomes Research (Early Stage Pipeline) will be responsible for defining and executing early evidence generation strategies and deliverables across multiple programs.

This role sits within New Product Planning/Global Product Strategy and Operations and requires an understanding of strategic input to clinical trials planning and evaluation, expertise in methods of economic evaluation, comparative effectiveness, and identification of value drivers.

RESPONSIBILITIES:

Trial Design & Endpoint Strategy and Specification

• Support HEOR/COA endpoint strategy from Phase 1 to 3 clinical studies ensuring inclusion of patient-centric, clinically meaningful, and economically relevant outcomes.
• Contribute to commercial and global market access strategy to influence trial designs that meet expectations from multiple stakeholders.
• Support target product profile development, testing and interpretation.
• Input to HTA scientific advice and Joint Clinical Assessment (JCA) planning.
• Lead input to study protocols, engagement with clinical operations and data management, and contribute to statistical analysis plans.
• Demonstrated ability to work with biostatisticians.
• Understanding of “fit-for-purpose” COAs and familiarity with evidentiary requirements for de novo development/modification under FDA Patient-Focused Drug Development (PFDD) guidance.
• Knowledge of applications of real-world evidence approaches within clinical development (e.g., external control arms, natural history data).

Health Economic Modeling & Comparative Effectiveness

• Lead development of HTA-grade cost-effectiveness and budget-impact models to support early decision-making, identify value drivers, pricing, value dossiers, and individual country-specific submissions.
• In-depth understanding of modeling specification methodologies, analyses, and interpretation to translate findings into value and pricing strategies. Demonstrated first-hand experience in running modeling scenarios is an expectation for the role.
• Lead indirect treatment comparison studies, evidence reviews, and meta-analyses.

HEOR Value Evidence Strategy

• Contribute to global HEOR evidence-generation strategies by asset, aligning development programs with regulatory, HCP, and payer/HTA expectations.
• Partner with Global/US Market Access and Regulatory to ensure pivotal studies capture relevant endpoints.
• Contribute to development of a cohesive evidence-based value narrative through launch, covering disease burden, unmet need, clinical benefit, and economic value.
• Represent HEOR in development of Integrated Development Plans (IDPs) and Integrated Evidence Generation Plans (IEGPs).
• Contribute to identification of evidence gaps and strategies (e.g., ITCs, RWE, COA development)

External Engagement & Communication

• Build relationships with clinical and HEOR/HTA thought leaders and academic collaborators shaping input to specific projects and methodologies, particularly in rare disease; contribute to business development activities and support existing Ionis business partnerships.
• Contribute to engagements with advisory boards, industry consortia, and patient advocacy organizations.
• Lead publication development and submissions to peer-reviewed journals and conferences; candidate is expected to have led/co-authored scientific communications.

REQUIREMENTS:

• Advanced degree(s) (MD, PhD, PharmD, MSc, MPH, or equivalent) in Health Economics, Outcomes Research, Economics, Health Services Research, Business or psychometrics.
• Associate Director: 8+ years and a master’s degree; or a PhD with 5+ years’ experience in pharmaceutical, biotechnology, or HEOR consulting environments; rare disease or neurology/cardiometabolic experience preferred.
• Director: 12+ years and a master’s degree; or a PhD with 8+ years’ experience in pharmaceutical, biotechnology, or HEOR consulting environments; rare disease or neurology/cardiometabolic experience preferred.
• Excellent communicator with proven interpersonal skills and ability to influence R&D, Commercial, Medical, and Regulatory teams.
• Strong scientific writing and oral presentation skills.
• Travel expectation is 30%

The role requires experience in the following two major areas in order for the candidate to be successful:

• Input to clinical trial design and endpoint strategy and specification, data collection, analysis, and interpretation of trial-based health economic and clinical outcomes assessment (COA) measures.
• Solid, firsthand experience with analysis of HTA-grade cost-effectiveness and budget-impact models; experience with evidence development for payer/HTA early scientific advice is a plus.

Remit does not include post-approval real-world evidence generation which is led by Medical Affairs.

We are considering candidates at the Associate Director and Director levels. Final title will be determined based on alignment with our level requirements.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003908

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits

The pay scale for this position is $180,000 to $250,000
The pay scale for the Associate Director position is $180,000 to $200,000
The pay scale for the Director position is $230,000 to $250,000

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

#LI-Remote