Gamida Cell is a clinical-stage biopharmaceutical company committed to developing novel cell therapies with the potential to cure difficult-to-treat cancers and rare, serious hematologic diseases. We are leveraging our proprietary nicotinamide-based cell expansion technology, or NAM technology, to develop product candidates designed to address the limitations of current therapies. Gamida Cell is a publicly traded company (Nasdaq: GMDA).
Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy in development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers.
The Senior Director, Global Health Economics & Outcomes Research (HEOR) will play a critical and significant role in the growth of Gamida Cell as an organization and in the successful commercialization of its novel cellular therapy pipeline products. The HEOR lead will work at a global level to lead the development of HEOR research strategies and plans to support optimal market access for the therapies. In addition, they will support the development and submission of in-country Health Technology Assessment (HTA) and Pricing & Reimbursement (P&R) submissions. The person in this leadership position will also represent HEOR at internal review groups and in front of Executive leadership as well as to our external Market Access customers.
The Sr. Director of Global HEOR will:
- Develop global HEOR strategies including analyses of currently available data and generate plans to fill identified gaps.
- Develop HEOR engagement strategies specific to payers and stakeholders in the US, Europe and Israel.
- Manage relationships with external consultants to ensure timely completion of high-quality projects aligned to strategic objectives.
- Design, implement, and manage HEOR projects, including but not limited to:
- Retrospective database analyses o Heath economic models.
- Budget impact models.
- Chart reviews.
- Real world evidence o Literature searches and systematic review.
- Support development and maintenance of global value dossiers.
- Identify appropriate data sources to support the projects described above.
- Conduct economic analyses and/or conduct detailed reviews of existing analyses.
- Work with KOLs to implement HEOR plans.
- Communicate study plans, study methods and results to internal teams.
- Present health outcomes research findings at scientific congresses and participate in the development and writing of manuscripts for publication in peer-reviewed journals.
- Build strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners on HEOR projects.
- Represent HEOR on cross-functional internal teams.
- Remain current on HEOR data sources and analytical methods.
- Work with clinical development teams to identify appropriate trial endpoints for products in development.
- Work closely with US and Israeli colleagues, and external consultants to develop strategies specific to US, European or Israeli payers and stakeholders.
- Lead consultancy support in the development of in-country HTA and P&R dossiers.
- Identify appropriate US, European or Israeli data sources.
- Other projects and activities as assigned.
- Proven expertise in Health Economics / Outcomes Research.
- At least 5 years pharma/biotech experience with HEOR strategy and implementation in US and Europe.
- Understanding market access and how HEOR evidence supports access decisions.
- Country and regional/global experience within a pharmaceutical company or consultancy
- Hematology/oncology experience required.
- Cell therapy, rare disease, orphan or ultra-orphan product experience highly desirable.
- Life sciences degree; post-graduate degree preferred.
- Excellent verbal and written communication skills.
- Excellent analytical skills, including in-depth knowledge of health economic modeling.
- Experience in managing multiple projects across a variety of health outcomes methodologies and therapeutic areas.
- Solid understanding of epidemiology and biostatistics.
- Minimum masters degree, scientific or technical area.
- Preferred advanced degree related to health economics and/or outcomes research.
- Fluent in English, written and oral.
- Travel: Up to 40%, once travel resumes