Operations Specialist, 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 Operations Specialist, Nonclinical Development is responsible for organizing and tracking the contracts and materials related to the nonclinical in vitro, in vivo, and bioanalytical work for preclinical/clinical programs.  This position, reporting to the Director, Preclinical Development, will be responsible for Contract Research Organization (CRO) vendor management, contract development, and contract management. They will assist the project/department representatives in nonclinical study start-up and maintenance activities, as well as reporting nonclinical study results. Specific tasks include new vendor onboarding, communicating with contract research organizations (CROs) for quotes, facilitating contracts, QA audits, collaborating with the legal department on service agreements, management of reagent purchasing and inventory, coordinating and tracking shipments/receipt, receiving invoices in purchasing system, and receiving, qualifying, and processing data sets from CRO and generating figures to support nonclinical reports and regulatory submissions.

The Operations Specialist, Nonclinical Development will work closely with the CMC team to ensure test article availability, qualification, shipment logistics, and documentation are in place They will also work closely with Regulatory Affairs to prepare, format, and publish documents to support regulatory submissions, Investigator Brochures, etc.

Visterra is seeking a collaborative, enthusiastic and flexible candidate with a scientific educational background and vendor management experience. The ideal candidate will have familiarity with animal research and the execution of in vivo studies as well as basic knowledge of the drug development process. This role will require occasional early morning and evening virtual meetings.

This is a full-time position based in Visterra’s facility in Waltham, MA.

Responsibilities

• Work with CROs, the Legal department, and Visterra management to execute service and confidentiality agreements.
• Work with CROs and the Accounting department to arrange quotes/contracts.
• Manage, communicate, and ensure adhesion to study timelines and milestones.
• Receive invoices from CROs and route for approval to the relevant team leader.
• Receive, review, and qualify data sets from CROs and process data to generate tables, figures, and listings to support nonclinical study reports and regulatory submissions.
• Collaborate with external vendors for the transfer of materials, study samples and reagents.
• Collaborate with the CMC team to ensure test article availability, qualification, and documentation.
• Maintain inventory of critical reagents and samples for Bioanalysis.
• Draft, format and/or review documents, protocols, reports etc. to support regulatory submissions.
• Other duties and responsibilities as required by departmental and business needs.

Requirements

• BS in a scientific field.
• At least 3 years’ experience in the pharmaceutical, biotechnology, and/or CRO industry.
• Familiarity and working knowledge of a broad range of nonclinical studies relevant to drug development (Toxicology, PK, Bioanalytical, Biology, Pharmacology).
• Intermediate to advanced proficiency using Microsoft Word, PowerPoint, Excel and GraphPad Prism.
• Ability to learn and use additional software as needed for data organization, tracking and presentation.
• Familiarity with drug development is highly desirable.
• Familiarity with accounting and budgetary tracking is highly desirable.
• Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
• Demonstrated ability to be a team player who thrives in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.
• 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.