Purpose and Scope
The Senior/Executive Director, Outcomes Research (Health Economics and Outcomes Research – HEOR) is a strategic leader responsible for developing and executing outcomes research strategies across the oncology portfolio, including solid tumors and hematologic malignancies. This role ensures generation of robust real-world evidence and health economic data to support product value, regulatory strategy, and market access in a highly complex and evolving oncology landscape. The role partners cross-functionally to translate clinical, epidemiologic, and economic insights into evidence that demonstrates value to oncologists, payers, health systems, and policy stakeholders.
Essential Duties & Responsibilities
- Strategic Leadership & Evidence Generation: Define and lead oncology-specific HEOR strategy across pipeline and in-line therapies. Ensure incorporation of oncology endpoints such as overall survival, progression-free survival, and quality of life outcomes.
- Health Economics & Value Demonstration: Oversee development of oncology-specific economic models including cost-effectiveness and budget impact models, incorporating treatment pathways, combination therapies, and line of therapy considerations.
- Real-World Evidence & Data Strategy: Lead RWE initiatives leveraging oncology registries, claims, EHRs, and genomic datasets to evaluate treatment patterns, outcomes, and comparative effectiveness.
- Cross-Functional Collaboration: Partner across Clinical Development, Medical Affairs, Market Access, and Commercial teams to align evidence generation with oncology treatment paradigms and competitive landscape.
- Market Access & Stakeholder Engagement: Develop payer and HTA-ready oncology value narratives and tools, including AMCP dossiers and briefing materials tailored to oncology reimbursement frameworks.
- People Leadership: Build and lead a high-performing oncology HEOR team, ensuring strong scientific and strategic capabilities.
Detail:
- Integrated Evidence Strategy
- Build and own the Integrated Evidence Plan (IEP) for P3 products, aligned with Clinical Development, Medical, Market Access, and Commercial strategy, and refresh it through launch and lifecycle.
- Run a structured evidence gap assessment across clinical, economic, humanistic, and real-world domains; prioritize studies by decision impact, feasibility, timing, and cost.
- Translate stakeholder evidence needs (payers, IDNs, oncology practices, NCCN and pathway committees, patients) into a sequenced, budgeted study portfolio.
- Extend the evidence planning framework to current commercial assets, and business development assets under evaluation.
- Real-World Evidence Generation
- Design and lead retrospective and prospective RWE studies, addressing (among other aspects) healthcare resource utilization, and cost of care.
- Evaluate and contract real-world data sources, such as oncology EHR-derived datasets, open and closed commercial claims, specialty pharmacy and hub data, laboratory data, and tokenized linked data, and set standards for data quality, fitness-for-purpose, and bias control.
- Develop protocols and statistical analysis plans with advanced methods (e.g., propensity score approaches, target trial emulation, external control arms where appropriate), consistent with FDA RWE guidance and ISPOR/ISPE good practices.
- Lead patient-centered outcomes work, including patient-reported outcomes, treatment burden and preference studies, and quality-of-life evidence relevant to young women on long-term OFS.
- Scope pragmatic, registry, and investigator-initiated research opportunities in partnership with Medical Affairs and academic centers.
- Health Economics & Value Demonstration
- Direct development of US budget impact and cost-effectiveness models, including commercial payer and employer perspectives, and adapt them for IDN, oncology practice, and pathway audiences.
- Own the AMCP Format dossier and pre-approval information exchange materials, working within FDA guidance and Legal/Compliance review.
- Prepare Tolmar for external value assessments (e.g., ICER) and support compendia, NCCN, and pathway submissions with Medical Affairs.
- Partner with Market Access and Pricing to inform pricing strategy, contracting, and site-of-care economics with credible evidence, without compromising scientific independence.
- Scientific Communication
- Own the HEOR/RWE publication plan: abstracts, posters, and manuscripts at forums such as SABCS, ASCO, ESMO Breast, ISPOR, and AMCP.
- Serve as Tolmar’s scientific voice on evidence with payers, HTA bodies, KOLs, and data partners; support field medical and account teams with approved, fair-balanced evidence resources.
- Build a scientific advisory network of outcomes researchers and breast oncology clinicians to pressure-test study designs.
- Function Building, Governance & Vendors
- Build the HEOR/RWE function: operating model, SOPs, study review and approval process, and data governance aligned with privacy (HIPAA) and data-use agreement requirements.
- Recruit, lead, and develop a team in next 18-36 months (across RWE science, health economics, and analytics), balancing in-house capability with specialized vendors.
- Select and manage HEOR consultancies, RWD providers, and CROs; own the evidence budget and deliver studies on time and on budget.
- Ensure all evidence activities comply with FDA, OIG, and PhRMA Code expectations, and maintain clear separation between scientific exchange and promotion.
Knowledge, Skills & Abilities
- Deep expertise in oncology outcomes research methodologies, clinical endpoints, and real-world evidence generation.
- Strong understanding of oncology treatment landscapes, evolving standards of care, and competitive dynamics.
- Ability to translate complex oncology data into strategic insights.
- Strong executive presence and communication skills.
- Advanced knowledge of HEOR study design, observational research, comparative effectiveness research, epidemiology, patient-reported outcomes, and health economic modeling approaches relevant to oncology.
- Demonstrated ability to develop integrated evidence generation plans that align clinical development, medical affairs, market access, regulatory, and commercial objectives.
- Strong understanding of payer, health technology assessment, and reimbursement requirements, including evidence needs for value dossiers, formulary decisions, and coverage discussions.
- Proven ability to evaluate and apply real-world data sources, including claims, electronic health records, registries, chart reviews, and other oncology-specific datasets.
- Ability to critically assess scientific literature, clinical trial data, treatment guidelines, and external evidence to inform research priorities and strategic recommendations.
- Excellent leadership, coaching, and talent development skills with the ability to build, mentor, and retain high-performing scientific teams.
- Strong project management and prioritization skills with the ability to manage multiple studies, vendors, budgets, timelines, and cross-functional deliverables.
- Knowledge of applicable regulatory, legal, privacy, publication, and compliance requirements related to outcomes research, real-world evidence, and external stakeholder engagement.
- Ability to influence senior leaders and external stakeholders through clear, credible, data-driven communication and strategic storytelling.
Leadership Competencies
- Scientific rigor. Holds a high bar for study design and honest interpretation; flags limitations rather than overstating results.
- Builder mindset. Comfortable creating process, team, and partnerships from a blank page with limited resources.
- Commercial fluency. Understands how payers, pathways, and practices make decisions, and designs evidence that answers those decisions.
- Cross-functional influence. Aligns Medical, Access, Commercial, and Clinical around one evidence plan and negotiates priorities transparently.
- Explains complex methods and economic results clearly to executives, clinicians, and payers.
- Manages multiple studies, vendors, and budgets with discipline against launch-critical timelines.
Core Values:
This position is expected to operate within the framework of Tolmar’s Core Values
- Center on People:We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization.
- Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve:We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Education & Experience
- Advanced degree required (PhD, MD, MPH) in relevant scientific discipline.
- Demonstrated expertise in Epidemiology and biostatistics related to design and analysis
- Familiarity with relevant datasets in US and abroad with a focus on peculiarities of each and the ability to advise on choices for analysis
- 12+ years of experience in HEOR, Market Access, or Medical Affairs within the pharmaceutical/biotech industry.
- Oncology experience strongly preferred, with demonstrated success in evidence generation and payer engagement.
Preferred
- Experience with physician-administered, buy-and-bill products and Part B / commercial medical benefit economics.
- Experience in a smaller or growing company where the candidate built a function, not only operated within one.
- Exposure to ICER assessments, NCCN or pathway submissions, and IDN/oncology practice value discussions.
- Patient-reported outcomes and preference research experience; familiarity with women’s health or survivorship populations.
- Experience supporting portfolio or business development evaluations with evidence assessments.
Working Conditions
Compensation and Benefits
- Annual pay range $300,000 - $325,000
- Bonus eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
