Position: Associate Director, SaMD (Software-as-a-Medical Device) Launch
Job #: 2483
Location: Northern NJ/Hybrid – in office 2-3 days per week
Compensation: Based Upon Experience
Summary: The Associate Director, SaMD (software-as-a-medical-device) Launch and Access will cultivate new pathways to achieve reimbursement and eventual commercialization of a SaMD product. Industry is in the early days of developing SaMD reimbursement schemes, and you will stay on top of the ever-evolving digital health landscape, research, identify and develop the best path forward, implement the strategy, and follow through on the execution. The role requires experience in HEOR/RWE study planning and implementation, value-based care models, patient and HCP and payer engagement, and go-to-market strategy planning. If you have cumulated operational experience in the highly regulated pharmaceutical or medical device environment and are motivated in new business incubation to digitally transform traditional healthcare towards much improved patient journey and lifecare for people, we want to hear from you.
Essential Functions:
Identify appropriate health system candidates and enter an HEOR study partnership. Lead partnership discussion including writing of protocols and analytic plans for prospective and retrospective research. Establish consensus on study design, level of EHR integration, publication rights. Cross-functionally collaborate with internal and external stakeholders along the process.
Plan, execute and manage the overall HEOR study from start through completion. Develop study protocol, orchestrate IRB review and implement the HEOR study including oversight on data analysis. Cumulate insights from various stakeholders as to how best to carry these out. Involve, select and manage CROs as appropriate.
Lead real world data generation, health economic models that supports product value assessment. Leverage compelling health economic endpoints and accomplish payer coverage.
Pursue value-based agreement opportunities with healthcare systems whenever applicable.
Train, onboard and support patients and HCPs on continued SaMD utilization throughout the SaMD product lifecycle.
Publicize study results through partnership with Medical Affairs.
Engage with industry trade associations and become a part of their legislative efforts on increased and improved access of SaMD.
Determine pricing based on latest learnings, design sustainable business model and go to market strategies.
Requirements:
At minimum a master’s degree in health services research, public health, epidemiology, statistics, health economics.
MBA also preferred.
Minimum 7 years of working experience at pharmaceutical/medical device companies in an HEOR/RWE or at provider/payer organizations in a formulary design role.
Track record in structuring and negotiating value-based care contracts.
Excellent communication and presentation skills are required
Expect to travel up to 20-25% of month during project peak times.
Working experience in Oncology Care Models, Oncology Care First Models a plus.
Companion Diagnostics, Digital Therapeutics experience a plus..