Principal Scientist, Nonclinical Development

Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases and other hard-to-treat diseases. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs.

Visterra is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 85 employees and is located in Waltham, Massachusetts.

Summary

The Principal Scientist, Nonclinical Development is responsible for supporting activities related to transitioning drug development candidates into early clinical studies with a focus on managing preclinical studies performed at CROs to enable first in human studies. Reporting to the Director, Preclinical Development, the Principal Scientist, Nonclinical Development will be responsible for activities related to drug development candidates.  This person will oversee the execution of experiments to support IND filings and early development with internal staff and external CROs. 

Visterra is seeking a flexible candidate with a broad-based knowledge of immunology and biologics drug development.  This individual will be responsible for the design, execution and interpretation and reporting of preclinical studies in late-stage research transitioning to preclinical development.  The successful candidate will be a collaborative team player, a critical thinker, and clear communicator.

This is a full-time position based in Visterra’s facility in Waltham, MA with potential flexibility with working remotely as workload and scheduling allows.

Responsibilities

• Develop preclinical strategies for drug development candidates.
• Facilitate contract research organization (CRO) vendor selection and due diligence activities including negotiating contracts, SOWs, and approval and full execution.
• Establish consulting agreements for toxicology/subject matter consultants.
• Develop and maintain collaborative relationships with CROs.
• Interface with CROs to request slot availability and request quotes for the planned nonclinical studies.
• Collaborate with cross-functional teams to design, execute, and monitor exploratory and GLP nonclinical safety studies.
• Present data at cross-functional team meetings and to senior management.
• Coordinate drug delivery to CROs in conjunction with our internal Pharmaceutical Science and Technology (PST) team representatives.
• Coordinate study samples receiving, distribution, analysis and archiving.
• Take the lead in actively tracking nonclinical safety, and safety pharmacology study related activities including authoring reports summarizing nonclinical studies to support regulatory submissions.
• Monitor the performance of non-clinical studies remotely at CROs.
• Obtain purchase orders for nonclinical studies performed at CROs and receive invoices to track spend against PO.
• Create and maintain timelines for nonclinical studies.
• Review, maintain, and update database (raw data and reports) of toxicology projects/programs.
• Work collaboratively with internal and external cross-functional teams or stakeholders, for example Regulatory and PST.
• Working knowledge in data spreadsheets (Excel) and GraphPad Prism to generate graphic illustrations of data received from CRO to support internal reports and regulatory submissions.

Requirements

• A minimum of five years of working experience, including a strong track record of hands-on experience in R&D and the biotechnology industry.
• Ph.D. or M.S. (1-5 years of experience) in Immunology, Biology or related field of study.  A BS with extensive experience can replace advanced degrees.
• Working experiences with biologics is highly desirable.
• Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for nonclinical drug development in support of first in human clinical trials.
• A proven track record in development, experience with biologics and an understanding of FDA and EMA guidelines. 
• Experience in outsourcing and managing CROs for regulated (GLP, GCP) studies.
• The ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audiences both internal and external, and excellent written skills.
• Excellent organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
• This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards.
• Limited travel (< 5%) may be required to attend conferences and industry events.

Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.