Sr. Scientist, Preclinical Development

Visterra•Waltham, MA

48d•Onsite

About The Position

The Sr. Scientist, Preclinical Development is responsible for activities related to transitioning drug development candidates into early development with a focus on the execution of preclinical studies to support health authority submissions (i.e. IND, CTA). The Sr. Scientist will collaborate with Research teams positioning their pipeline programs to make the Research to Development transition through candidate screening, hit to lead, and final candidate nomination. The Sr. Scientist will work side by side with their research team colleagues to ensure a smooth transition of lead candidates into early clinical development. This includes obtaining a deep understanding of the target biology and the drugs mechanism of action to facilitate the design and management of non-regulated pharmacokinetic and pharmacodynamic studies in relevant species. The Sr. Scientist will collaborate with the Research team to document all preclinical PK/PD study findings and contribute to the pharmacology sections of regulatory submissions. Visterra is seeking a flexible candidate with a broad-based knowledge of immunology and biologics drug development. The primary focuses will be in vivo pharmacology, defining pharmacodynamic endpoints, establishment of pharmacokinetic/pharmacodynamic relationships and identification of key efficacy thresholds, as well as immunogenicity assessments and mechanistic studies addressing mechanism of action and safety. This individual is responsible for design, technical oversight, and documentation for preclinical programs. The individual will actively participate in program teams, as well as collaborate effectively across functions. 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 is an onsite position in Waltham, MA.

Requirements

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.
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.

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.

Benefits

We provide comprehensive benefits and resources to support your work, life, and balance.
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.