Senior/Principal Scientist, In Vivo Pharmacology Lead
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 multicenter 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.
Rakuten Medical is searching for a highly motivated individual to lead Rakuten Medical’s preclinical in vivo pharmacology team. In this role, he/she will be the key in vivo pharmacology expert in a multidisciplinary research team. The candidate will guide, design, and assist with executing studies to evaluate efficacy and mechanism of action of hit and lead candidate products utilizing the most appropriate in vivo pharmacology models. This individual will participate and present data at weekly research meetings, and interface with other key functions such as Immunology, Technical Operations, Biologics and Protein Engineering, etc. As the scientific and technical lead, the successful candidate is also expected to train other members of the multidisciplinary research team in scientific, technical, and operational aspects. In alignment with the Rakuten Medical company culture, the individual will be expected to perform these duties in a highly collaborative manner with other members of the multidisciplinary research team, and will also have the opportunity to learn and grow in other functions.
Key Duties and Responsibilities
- Serve as a scientific and technical leader to lead and guide execution of in vivo pharmacology studies to demonstrate efficacy and characterize mechanism of action of lead targets in immunocompetent and immunocompromised mouse models.
- Guide, design, and assist with executing in vivo pharmacology studies to accomplish the goals of the Translational Research team.
- Work collaboratively with other members of the Translational Research team to guide studies for evaluating efficacy and characterizing immune-based mechanism of action of lead molecules, and also develop the most effective translational models for immuno-oncology.
- Train and support personnel to manage and execute complex experimental testing and models.
- Identify gaps in knowledge or expertise in In Vivo Pharmacology, resolve scientific or technical challenges with sophisticated approaches including, as needed, the development and implementation of new assays or new models to test hypotheses and answer complex scientific problems.
- Demonstrate innovation in research/planning and expected to be able to make intellectual property submissions.
- Keep accurate records and enter data into an electronic laboratory notebook in a timely manner.
- Follow laboratory safety guidelines and practices.
- Contribute to the writing of publications and regulatory documents to support regulatory filings of non-clinical experimental data.
Desired Education, Skills and Experience
- Ph.D. with minimum 7+ years pharmaceutical industry experience directing in-vivo pharmacology studies in the area of oncology and with experience in syngeneic models and the testing of immune modulatory agents.
- Comprehensive understanding of the development of new therapies from preclinical to clinical and including regulatory processes needed to support R&D and final approval of BLA/NDAs.
- Demonstrated experience leading projects and programs in a pharmaceutical setting with successful translation into the clinic.
- Deep understanding of immunology, especially in the cancer immunology, as demonstrated by publications in top tier scientific journals.
- Experience with a variety of in vivo translational model systems to demonstrate mechanisms of action (immunocompetent and immunocompromised mouse models, GEMM, PDX, etc.)
- Superior technical expertise with standard in vivo techniques, including dosing and sampling routes (e.g., po, ip, sc, iv dosing; submandibular, retro-orbital, cardiac bleeds; necropsy and organ/tumor harvest) and tumor measurements is required.
- Competency with mouse surgical techniques (stereotactic implants, orthotopic implants, etc.) will also be highly valued.
- Experience with ex vivo techniques and analysis (tissue extraction, single cell dissociation, multi-color flow cytometry to analyze tumor infiltrates) will be highly preferred.
- Experience working with antibody-based therapeutics.
- Experience with IACUC and AAALAC.
- Excellent communication skills, organizational skills and the ability to work independently and in a matrix team environment are essential.
- Excellent emotional intelligence and sound character.
- Able to occasionally work weekends as study schedules dictate.
- Alignment with company and research team values.
- Must be able to lift up to 25 pounds.
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.