Senior Principal Scientist, Biomarkers

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Our Brand Concept

• On a mission: Empowerment

We Pioneer compassionate approaches to treat cancer.

As a global organization, we seek to empower patients and their families, and the healthcare community to engage, collaborate and take control of their cancer journey to achieve positive treatment outcomes.

• Behave Ethically: Integrity

We believe in the power of "Shinrai" (trust). We hold ourselves accountable to patients, families and the healthcare ecosystem.

• Prepare to Succeed: Professionalism

We are prepared and tackle challenges with fresh thinking and out-of-the-box solutions.

• Complete Commitment: Get Things Done

We are action-driven, and exceed outcomes with urgency, while being nimble and resourceful.

• Solidarity: Succeed as a Team

The team starts with each of us. We collectively align to exceed outcomes.

Position Summary

Rakuten Medical is seeking a highly motivated and experienced Senior/Principal Scientist to support our clinical programs by evaluating the pharmacodynamic responses to treatment and discovering biomarkers associated with patient response, with a focus on immuno-oncology. This position will report to the Vice President, Pre-Clinical Research and Development (PCRD), within the PCRD functional team, based in San Diego, CA. This individual will serve as the Biomarker Lead on global program teams, setting up biomarker plans for individual trials and ensuring appropriate collection and timely analysis and reporting of final biomarker data. The individual will be responsible for answering key biomarker questions related to the assigned programs in collaboration with the PCRD team and Clinical Science (CS) team.

This role requires a solid understanding of clinical biomarkers from start to finish: Implementation in clinical protocols and lab manuals, experience working with CROs and operationalizing Good Clinical Practice (GCP), and execution and interpretation of the assays.

The candidate should have extensive expertise with multiplex immunofluorescence, multiplex flow cytometry, and gene expression evaluation from large sequencing datasets. This person will provide scientific and technical guidance and support in these methods and analyses for the translational research team, as needed. The candidate should be experienced in immuno-oncology as evidenced by peer-reviewed publications and scientific presentations. The candidate must be flexible, a go-getter, have a strong collaborative spirit, and should expect to work in a highly cross-functional environment with members from other departments across Global time zones.

Key Duties and Responsibilities, including but not limited to:

• Designs and implements program-specific early and late-stage development biomarker/translational plans, responsible for supporting the creation of clinical protocols, SOWs, lab manuals, and interfacing with CRO for execution of services, in collaboration with global Clinical Operations
• Determines appropriate assays and vendors for clinical biomarkers, and manages outsourcing of biomarker assay development and validation partnering with PCRD colleagues when applicable
• Manages clinical biomarker data delivery and analysis and associated timelines by working with relevant internal functions and CROs
• Prepares and delivers internal and external translational/biomarker presentations
• Maintains timelines for biomarker data related publications through interaction with Medical Affairs team as needed
• Keeps up-to-date on relevant scientific/technical literature in order to apply external knowledge to internal research programs as appropriate and acts as a subject-matter expert within the team to critically evaluate the literature regarding the asset and disease biology
• Works with PCRD laboratory scientists and academic thought leaders to address nonclinical translational questions
• Participates in post-hoc biomarker analysis and publication efforts

Education

• PhD or equivalent in a life science discipline or related field and > 6 years of relevant industry experience or
• MS in a life science discipline or related field and > 10 years of relevant industry experience

Required Skills and Experience

• Working knowledge and expertise in multi-color immunofluorescence, including panel design, validation, image capture and population analysis; Hands on experience with Leica bond, Akoya Phenoimager, and HALO software a plus
• Working knowledge and expertise in multi-color flow cytometry, including panel design and analysis; Hands on experience with FlowJo software required
• Working knowledge and expertise in high-dimensional molecular data, particularly genetic, RNAseq, and/or single cell data
• Experience in outsourcing and managing external collaborations
• Prior experience with clinical trial protocols, lab manuals, and central lab documentation, including GXP knowledge and experience
• Ability to manage multiple activities related to assigned projects with minimal supervision
• Ability to work effectively and collaboratively in a fast-paced, dynamic environment
• Excellent communication, technical writing, organizational and collaboration skills
• Alignment with Rakuten Medical company values

The expected salary range for this position based in California is $100,000 to $130,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

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 for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. 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.