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Waltham, MA Full Time Posted by: Visterra, Inc. Posted: Thursday, 25 November 2021
 
 

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 Senior Scientist, Nonclinical Development is responsible for supporting activities related to transitioning drug development candidates into early clinical studies with a focus on in vivo pharmacology studies to support characterization of pharmacokinetics, pharmacodynamics and safety of drug development candidates. Reporting to the Director, Nonclinical Development, the Senior Scientist will be responsible for activities related to drug development candidates. They will oversee the execution of experiments to support Investigational New Drug (IND) filings with internal staff and external Contract Research Organizations (CROs). Visterra is seeking a flexible candidate with a broad-based knowledge of immunology and biologics drug development. The primary foci for this role will be in vivo pharmacology, defining pharmacodynamic endpoints and mechanistic studies addressing mechanism of action and safety. This individual is responsible for the design, technical oversight, outsourcing, collaboration oversight, and documentation for preclinical programs. This individual will actively participate in program teams, as well as collaborate effectively across functions.

Visterra is seeking a collaborative, enthusiastic and flexible candidate with a scientific educational background and vendor management experience. The successful candidate shall demonstrate a proven track record in development and have experience with biologics and understanding of INDs and FDA/EMA guidelines. This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards. 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

  • Oversee external contractors and internal staff to enable the development of appropriate preclinical in-vitro and in-vivo models and procedures to support development programs.
  • Oversee and conduct preclinical efficacy and mechanism of action studies.
  • Review and analyze data to support late-stage research and development activities. Present data at cross functional team meetings, summarize data in reports to support IND filings.
  • Oversee method development at CROs to support pharmacodynamic assessments.
  • Establish and maintain high-quality systems for outsourcing, managing and reporting data from preclinical studies that meet both regulatory guidelines and industry best practices.
  • Effectively present data to mixed audiences including the executive team if required.
  • Prepare and review reports and packages for regulatory submissions.
  • A demonstrated strong ability to effectively communicate.
  • Proven ability to meet deliverables and timelines.
  • The interest and ability to maintain contemporary knowledge of current industry and regulatory trends, standards, and methodologies.
  • Other duties and responsibilities as required by departmental and business needs.

Requirements

  • A minimum of five (5) years of working experience in academia or the biotechnology industry, including a strong track record of hands-on experience in Research and Development.
  • An M.S. or Ph.D. in Immunology, Biology, or related field of study is preferable.
  • Candidates with a Bachelor of Science (BS) degree with significant research experience are also encouraged to apply.
  • Working experiences with biologics is highly desirable.
  • Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Nonclinical development in support of clinical trials.
  • Experience in outsourcing and managing CROs for regulated (GLP, GCP) studies.
  • Managerial experience and demonstrated effective leadership within cross functional teams.
  • The ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audience both internal and external, and excellent written skills.
  • 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.


Waltham, MA, United States of America
Healthcare
Visterra, Inc.
Click apply
JS11167_1903654436
11/25/2021 11:45:19 PM


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