Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost & complexity of dialysis. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients & operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere & by anyone. The integration of water purification & on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission & a proprietary data analytics platform powering a new holistic approach to dialysis care.
The Sr. Director, Clinical Evidence Development is responsible for leading all clinical & health economic evidence development to demonstrate the value of Outsets Tablo across all use environments (acute, subacute, chronic & home) to all stakeholders including patients, physicians, hospitals, dialysis providers, health systems, & integrated delivery networks. Working with the Chief Medical Officer, the Director will develop, design & execute comprehensive, multi-year evidence generation strategies & tactical plans aligned with the goals of the commercial organization to increase adoption & utilization of Tablo.
The ideal candidate should be well versed in clinical strategies to support medical device adoption as well as in the design, execution & oversight of clinical evidence development. They should be naturally curious & a creative problem solver with proficiency in facilitating cross-functional groups. The candidate must be able to develop, deliver & execute on a strategic & tactical plan based on input from both internal & external stakeholders. He or she should be passionate about serving customer & patient needs through cutting edge technology application & want to be a part of creating a paradigm shift in renal replacement therapy.
Essential Job Functions
- Work with the Clinical, Commercial, Marketing & Sales teams to develop & execute on a roadmap of projects to develop, communicate, & quantify evidence-based clinical & economic value propositions for Tablo across customer segments
- Direct & oversee the completion of clinical trials within defined timelines & budgets
- Collaborate & develop relationships with customers & key opinion leaders (KOLs) to create effective channels of communication & create partnerships in the generation of clinical evidence & formation of the value proposition
- Develop & execute an effective Investigator Sponsored Research (ISR) program
- Analyze & compare clinical data from multiple sources to identify significance, trends, & opportunities
- Direct the completion & publication of clinical research manuscripts
- Set & drive execution on Clinical KPIs
- Collaborate with the CMO on the development & execution of a clinical team growth strategy
- Support & develop clinical team members career growth
- Oversee & direct consultants in data analyses & medical writing projects that support the value proposition development
- Direct the internal dissemination of new clinical & economic value data
- Build new & strengthen existing relationships with investigators, research sites, & medical societies
- Identify opportunities for new avenues of clinical research within the current field of dialysis as well as adjacent areas.
- Bachelors degree required. Post graduate degree is preferred ( MD, PhD, RN)
- At least 10 years of experience in directing & managing clinical research.
- Previous work in a similar role in the medical device industry or dialysis industry is strongly preferred
- An understanding of clinical manuscript writing & the peer review publication process.
- Ability to analyze, interpret, & communicate clinical & health economic data, including an understanding of the statistical method.
- Proven experience integrating clinical & business data to assess or compare the clinical & economic value of clinical interventions or processes.
- Experience with implementation, integration & management of clinical reporting tools & data management software.
- Proven experience in relationship development with KOLs, investigators, hospitals & research teams in academic & nonacademic settings. Prior clinical trial experience within the Department of Veterans affairs preferred.
- Knowledge & experience in conducting an RFP process as well as the selection & management of CROs.
- Exceptional analytical, problem solving skills & attention to detail.
- Excellent oral & written communication skills
- Demonstrated experience in collaborating with cross-functional teams.
- Must be self-motivated, detail-oriented, creative, strategic, & highly organized
- Must have excellent writing, qualitative & quantitative analytical, & research skills
- Proven experience in creating a strategic work plan to set & achieve specific goals
- Experienced in working with people with diverse backgrounds