Principal Scientist, Biomarkers

Company Profile

Rakuten Medical, Inc., is a privately funded, clinical stage Biotechnology company with offices in the USA, Japan and Germany. Since 2013, Rakuten Medical has been developing new anticancer therapies based on the Photoimmunotherapy platform. Rakuten Medical plans to become a fully integrated biopharma with research, development, and world-wide commercialization of therapies based on the Photoimmunotherapy platform.

Our long-term objective is to commercialize a number of therapies based on Photoimmunotherapy to treat a broad range of solid tumor types as single agent and in combination with other immunomodulatory agents to generate robust and long lasting anticancer immunological responses.

Rakuten Medical is currently sponsoring a global Phase 3 multi-center clinical study to evaluate the efficacy and safety of ASP-1929 in patients with recurrent Head and Neck Cancer and additional Phase 2 studies to evaluate the safety and efficacy in patients with other cancer types.

Given the rapid progression of the clinical studies, we are quickly expanding the team to support late stage pivotal clinical development and future commercialization of our products.

Position Summary

Rakuten Medical is looking for a highly motivated expert in Biomarker discovery, correlative studies, and companion diagnostics development. The candidate will lead the design, investigate, and execute plans to discover or characterize biomarkers and companion diagnostics development that relate to disease subgroups and therapeutic response or describe mechanisms of therapeutic action. These biomarkers and companion diagnostics development will be used to support the execution of clinical studies and may be commercialized with the therapies that Rakuten Medical is developing.

Core responsibilities include authoring and leading the execution of research and discovery plans in biomarkers and companion diagnostics and supporting the integration of these biomarkers and companion diagnostics in clinical development including statistical analysis plans and logistics for sample collection and testing. This position will work in close collaboration with the biostatistical team as well as other teams related with R&D and clinical development.

Key Duties and Responsibilities

• Lead development of biomarker and correlative studies that interrogate the tumor status prior to or after treatment to evaluate patient populations that may be more responsive to treatment or interrogate mechanisms of drug action.
• Lead development of next generation biomarker and correlative studies to predict and evaluate anti-cancer immune responses, both at the tumor site (immune contextures) and systemically with liquid biopsies.
• Formulate immune mechanistic hypotheses on photoimmunotherapy and IO combinations and determine the best biomarkers and correlative studies to implement to predict therapeutic responses.
• Select CROs for execution and oversee assay deliverables.
• Support development of next generation companion diagnostics to support development and commercialization of Rakuten Medical’s Therapeutics.
• Coordinate with clinical operations team the collection, handling, storage and testing of biological specimens.
• Collaborate with bioinformatics to define bioinformatic data processing workflow and analysis.
• Support regulatory filings top secure the approval or companion diagnostics for commercialization.
• Collaborate with the biometrics team to develop SAPs for the statistical analysis of clinical outcomes and sub-populations based on specific biomarkers during clinical development

Desired Education, Skills and Experience

• PhD with 7+ years of industry experience in Immunology, Biomarkers or Translational Oncology.
• In-depth knowledge in immunoncology.
• Prior experience with exploratory immune biomarker discovery in oncology is required.
• Experience with antibody development and use of antibodies as biomarkers in IHC and IF platforms is preferred.
• Experience with clinical trial protocols and FDA regulatory processes for drug required and companion diagnostic development a plus.
• Proactively engages with teams to define crisp scientific questions that can be addressed with an appropriately powered experimental design.
• Proven track record in clinical study design, monitoring and execution and results analysis from biomarker perspective.
• Strong proficiency in managing workflows, priorities, and deadlines and managing multiple projects as part of a small team
• Willing to work with a fast pace technical operations / development group to ensure deliverables are met on-time.
• Strong written and verbal communication skills.

Physical Demands

• This position requires lab work, frequent sitting, computer operation, standing, walking, talking, and hearing.
• This position may require some business travel (including overnight stays and domestic and international travel) by air/rail/auto of approximately 1-5% of the working days buy travel schedule may vary to lower or higher amounts depending on the job demands.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.