Visterra Inc. · 2 months ago
Sr. Scientist, Preclinical Development
Waltham, Massachusetts, United States
Full-time
Onsite
Senior Level
5+ years expVisterra Inc. is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for patients with kidney diseases and other hard-to-treat diseases. The Sr. Scientist, Preclinical Development is responsible for overseeing preclinical studies and collaborating with research teams to transition drug development candidates into early clinical development, ensuring compliance with regulatory submissions.
BiotechnologyClinical TrialsHealth DiagnosticsTherapeutics
Responsibilities
Oversee external contractors and internal staff to leverage appropriate preclinical in-vitro and in-vivo models and procedures to support development programs
Oversee and conduct preclinical efficacy and mechanism of action studies
Prepare and review reports and packages for regulatory submissions
Identify translation biomarkers for pharmacology endpoints and oversee technology transfer if applicable for assay method development and validation to support regulated studies
Review and analyze preclinical study data to support late-stage research and development activities
Present data at cross functional team meetings, summarize data in reports to support IND filings
Organize reports (pharmacology, pharmacokinetics, toxicology) from research and preclinical groups and track statuses to support timely regulatory filings
Assist in collecting and summarizing data from reports into regulatory documents (from briefing books for early regulatory interactions through to IND modules and Investigator’s Brochures)
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’s best practices
Effectively present data to mixed audiences both internally and to external partners
Demonstrates a strong ability to effectively communicate in a cross-functional team setting
Proven ability to meet deliverables and timelines
Maintains a contemporary knowledge of current industry and regulatory trends, standards and methodologies
Performs other duties as required
Qualification
Required
A minimum of five years of working experience in academia or the biotech industry, including strong track record of hands-on experience in R&D
M.S. or Ph.D. in Immunology, Biology or related field of study is preferable. Candidates with a Bachelor of Science degree with significant research experience are also encouraged to apply
Working experiences with biologics drug discovery and development is highly desirable
Familiarity with antibody pharmacokinetics and WinNonlin software a plus
Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Nonclinical development in support of regulatory submissions
Experience in outsourcing and managing CROs for assay development and preclinical studies
Ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of audience both internal and external, excellent written skills
Benefits
A 401(k) retirement plan with a 10% dollar-for-dollar match.
Medical, dental and vision benefits, with Visterra contributing 85% to the monthly premium.
A rich mental & behavioral wellness program.
Short- and long-term disability programs.
Group and voluntary life insurance.
Pre-tax flexible spending and commuter accounts.
17 days of personal time, discretionary sick time, and 11 holidays per calendar year. Personal time accrual grows to 22 days after 3 years, with an additional one-time grants of 5 days every 5 years.
Twelve weeks of paid parental leave for birth or adoption.
A broad fitness reimbursement program.
Tuition and student loan reimbursement.
A variety of employee discounts.
Company
Visterra Inc.
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.
51-200 employees
H1B Sponsorship
Visterra Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (2)
2022 (3)
2021 (3)
2020 (4)
Funding
Current Stage
Growth StageTotal Funding
$125.39MKey Investors
Temasek Holdings
2018-07-11Acquired
2017-10-05Series C· $23.6M
2016-06-01Series C· $23.1M
Leadership Team
Brian Pereira
President & CEO & Board Member
P
Peter Courossi
Chief Financial Officer
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-02
prnasia.com
2025-08-29
Company data provided by crunchbase