Sr Director HEOR
Tolmar
Summary
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.
Job description
Essential Duties & Responsibilities
- Define and lead oncology-specific HEOR strategy across pipeline and in-line therapies.
- Oversee development of oncology-specific economic models including cost-effectiveness and budget impact models.
- Lead RWE initiatives leveraging oncology registries, claims, EHRs, and genomic datasets.
- Partner across Clinical Development, Medical Affairs, Market Access, and Commercial teams.
- Develop payer and HTA-ready oncology value narratives and tools, including AMCP dossiers.
- Build and lead a high-performing oncology HEOR team.
Integrated Evidence Strategy
- Build and own the Integrated Evidence Plan (IEP) for P3 products.
- Run a structured evidence gap assessment across clinical, economic, humanistic, and real-world domains.
- Translate stakeholder evidence needs into a sequenced, budgeted study portfolio.
- Extend the evidence planning framework to current commercial assets and business development assets.
Real-World Evidence Generation
- Design and lead retrospective and prospective RWE studies.
- Evaluate and contract real-world data sources.
- Develop protocols and statistical analysis plans with advanced methods.
- Lead patient-centered outcomes work.
- Scope pragmatic, registry, and investigator-initiated research opportunities.
Health Economics & Value Demonstration
- Direct development of US budget impact and cost-effectiveness models.
- Own the AMCP Format dossier and pre-approval information exchange materials.
- Prepare for external value assessments (e.g., ICER) and support compendia, NCCN, and pathway submissions.
- Partner with Market Access and Pricing to inform pricing strategy.
Scientific Communication
- Own the HEOR/RWE publication plan.
- Serve as scientific voice on evidence with payers, HTA bodies, KOLs, and data partners.
- Build a scientific advisory network.
Function Building, Governance & Vendors
- Build the HEOR/RWE function: operating model, SOPs, study review and approval process, and data governance.
- Recruit, lead, and develop a team.
- Select and manage HEOR consultancies, RWD providers, and CROs.
- Ensure all evidence activities comply with FDA, OIG, and PhRMA Code expectations.
Requirements
- 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.
- 12+ years of experience in HEOR, Market Access, or Medical Affairs within the pharmaceutical/biotech industry.
- Oncology experience strongly preferred.
- 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.
- Strong understanding of payer, health technology assessment, and reimbursement requirements.
- Proven ability to evaluate and apply real-world data sources.
- Ability to critically assess scientific literature, clinical trial data, treatment guidelines, and external evidence.
- Excellent leadership, coaching, and talent development skills.
- Strong project management and prioritization skills.
- Knowledge of applicable regulatory, legal, privacy, publication, and compliance requirements.
- Ability to influence senior leaders and external stakeholders.
- Preferred: Experience with physician-administered, buy-and-bill products and Part B / commercial medical benefit economics.
- Preferred: Experience in a smaller or growing company where the candidate built a function.
- Preferred: Exposure to ICER assessments, NCCN or pathway submissions, and IDN/oncology practice value discussions.
- Preferred: Patient-reported outcomes and preference research experience.
- Preferred: Experience supporting portfolio or business development evaluations with evidence assessments.
Benefits
- Bonus eligible
- Health benefits
Company overview
Tolmar is a fully integrated specialty pharmaceutical company founded in 2006, focused on the development, approval, and commercialization of innovative pharmaceutical products across urology, oncology, and dermatology therapeutic areas. The company has established itself as a leader in advanced long-acting injectable drug delivery technologies, with a particular emphasis on specialty injectables and prescription topical formulations. Tolmar's flagship products include ELIGARD® for advanced prostate cancer management, Fensolvi® for central precocious puberty treatment, and Jatenzo® for testosterone replacement therapy. With commercial headquarters in Buffalo Grove, Illinois and extensive manufacturing facilities in Colorado spanning over 340,000 square feet, Tolmar operates as a privately held organization with more than 1,100 employees. The company has successfully brought 22 marketed products to market supported by five New Drug Applications and 17 Abbreviated New Drug Applications, demonstrating its robust pipeline and commitment to addressing unmet medical needs through innovative pharmaceutical solutions.