Visterra Inc.
Director, Preclinical Development
Visterra Inc., Waltham, Massachusetts, United States, 02254
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Director, Preclinical Development
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Visterra Inc. This role is responsible for overseeing activities related to transitioning drug development candidates into early development with a focus on preclinical studies to support health authority submissions (e.g., IND, CTA). The Director will collaborate with Research teams to transition from Research to Development, directing non-regulated pharmacokinetic and pharmacodynamic studies, and developing and executing the preclinical in vitro and in vivo safety strategy, including GLP toxicology studies to enable first-in-human studies. The Director will ensure test article supply in collaboration with Pharmaceutical Sciences and Technology (CMC) and work with Bioanalytical teams to provide PK/PD/ADA assessments for non-GLP and GLP studies. Responsibilities include soliciting proposals, scoping work, CRO selection, contract negotiation, study protocol generation, execution, and final study reports. The Director will support programs from the R to D transition through GLP toxicology and safety pharmacology studies, chronic toxicology for proof-of-concept in patients, and, with Otsuka Pharmaceuticals Preclinical partners, later-stage preclinical studies to support development and safety in pursuit of BLA. Visterra seeks a candidate with broad immunology and biologics drug development knowledge. The role focuses on preclinical studies to support IND filings, balancing long-term strategy with tactical and detailed technical decision-making and project management. This individual provides technical oversight, outsourcing, technology transfer, and documentation for in vivo studies and supporting bioanalytical methods. The candidate will participate in program teams and collaborate across functions, with a proven track record in development and experience with biologics and FDA/EMA guidelines. The role requires strong analytical, goal-oriented, and timeline-sensitive work while maintaining high quality standards. This is an onsite position in Waltham, MA. Responsibilities
Develop preclinical program strategies for drug development candidates transitioning from Research to Development. Identify relevant species for pharmacology and toxicology assessment based on target cross-reactivity. Conduct in vitro and in vivo preclinical studies to inform safety liabilities for lead candidates. Author PK/PD and safety reports and provide Preclinical support during regulatory interactions. Provide scientific oversight of preclinical study execution and review preclinical data. Prepare RFPs, define study designs for SOWs, negotiate contracts, and oversee CROs responsible for preclinical safety/PK/PD assessments. Participate in cross-functional team meetings, present and summarize preclinical data, and coordinate with Program Management to align timelines and deliverables. Collaborate with clinical and translational teams to ensure preclinical strategy aligns with the clinical development plan and ensures safety margins for the intended clinical dose, frequency, and route of administration. Provide scientific input and oversight for development of preclinical study protocols. Contribute to regulatory submissions, including overseeing Module 2 content for INDs. Work with internal teams to build knowledge necessary to support drug development goals. Prepare and present scientific material for conference presentations or publications. Support programs at different development stages and oversee CRO selection, contract oversight, vendor management, and data analysis. Oversee completion of key program goals and deliverables related to preclinical development and communicate effectively across teams. Demonstrate the ability to meet deliverables and timelines. Performs other duties as required. Requirements
Ph.D. with 5-10 years of industry experience, or BS/MS with 10+ years of experience in biopharmaceutical development, with emphasis on preclinical safety. Experience with biologics and monoclonal antibodies is highly desirable. Experience outsourcing, vendor management, and interfacing with internal groups, including managing consultants and CROs to drive timely delivery of Preclinical study reports. Experience running GLP Toxicology studies. Experience representing Preclinical on cross-functional early-stage development teams and communicating Preclinical activities and results to support clinical investigations. Proven ability to work in a collaborative, cross-functional global environment. Strong knowledge of FDA, EMA, and ICH guidance including GLP regulations. Experience authoring Preclinical sections of INDs/CTAs and providing science-based regulatory responses. Understanding of QA, regulatory, and clinical functions to guide Preclinical safety assessment and support drug development goals. Ability to synthesize, interpret, and present diverse multidisciplinary data; strong oral and scientific writing communication skills. Ability to navigate, problem-solve, execute, and influence in a dynamic, fast-paced environment. 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. 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 grant 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. About Us
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for kidney diseases and other hard-to-treat diseases. Our proprietary technology enables the design and engineering of precision antibody-based product candidates that specifically bind to and modulate key disease targets. We are developing a robust pipeline of novel therapies for patients with unmet needs. Visterra is a wholly-owned subsidiary of Otsuka America, Inc., a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 125 employees and is located in Waltham, Massachusetts. 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.
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Director, Preclinical Development
role at
Visterra Inc. This role is responsible for overseeing activities related to transitioning drug development candidates into early development with a focus on preclinical studies to support health authority submissions (e.g., IND, CTA). The Director will collaborate with Research teams to transition from Research to Development, directing non-regulated pharmacokinetic and pharmacodynamic studies, and developing and executing the preclinical in vitro and in vivo safety strategy, including GLP toxicology studies to enable first-in-human studies. The Director will ensure test article supply in collaboration with Pharmaceutical Sciences and Technology (CMC) and work with Bioanalytical teams to provide PK/PD/ADA assessments for non-GLP and GLP studies. Responsibilities include soliciting proposals, scoping work, CRO selection, contract negotiation, study protocol generation, execution, and final study reports. The Director will support programs from the R to D transition through GLP toxicology and safety pharmacology studies, chronic toxicology for proof-of-concept in patients, and, with Otsuka Pharmaceuticals Preclinical partners, later-stage preclinical studies to support development and safety in pursuit of BLA. Visterra seeks a candidate with broad immunology and biologics drug development knowledge. The role focuses on preclinical studies to support IND filings, balancing long-term strategy with tactical and detailed technical decision-making and project management. This individual provides technical oversight, outsourcing, technology transfer, and documentation for in vivo studies and supporting bioanalytical methods. The candidate will participate in program teams and collaborate across functions, with a proven track record in development and experience with biologics and FDA/EMA guidelines. The role requires strong analytical, goal-oriented, and timeline-sensitive work while maintaining high quality standards. This is an onsite position in Waltham, MA. Responsibilities
Develop preclinical program strategies for drug development candidates transitioning from Research to Development. Identify relevant species for pharmacology and toxicology assessment based on target cross-reactivity. Conduct in vitro and in vivo preclinical studies to inform safety liabilities for lead candidates. Author PK/PD and safety reports and provide Preclinical support during regulatory interactions. Provide scientific oversight of preclinical study execution and review preclinical data. Prepare RFPs, define study designs for SOWs, negotiate contracts, and oversee CROs responsible for preclinical safety/PK/PD assessments. Participate in cross-functional team meetings, present and summarize preclinical data, and coordinate with Program Management to align timelines and deliverables. Collaborate with clinical and translational teams to ensure preclinical strategy aligns with the clinical development plan and ensures safety margins for the intended clinical dose, frequency, and route of administration. Provide scientific input and oversight for development of preclinical study protocols. Contribute to regulatory submissions, including overseeing Module 2 content for INDs. Work with internal teams to build knowledge necessary to support drug development goals. Prepare and present scientific material for conference presentations or publications. Support programs at different development stages and oversee CRO selection, contract oversight, vendor management, and data analysis. Oversee completion of key program goals and deliverables related to preclinical development and communicate effectively across teams. Demonstrate the ability to meet deliverables and timelines. Performs other duties as required. Requirements
Ph.D. with 5-10 years of industry experience, or BS/MS with 10+ years of experience in biopharmaceutical development, with emphasis on preclinical safety. Experience with biologics and monoclonal antibodies is highly desirable. Experience outsourcing, vendor management, and interfacing with internal groups, including managing consultants and CROs to drive timely delivery of Preclinical study reports. Experience running GLP Toxicology studies. Experience representing Preclinical on cross-functional early-stage development teams and communicating Preclinical activities and results to support clinical investigations. Proven ability to work in a collaborative, cross-functional global environment. Strong knowledge of FDA, EMA, and ICH guidance including GLP regulations. Experience authoring Preclinical sections of INDs/CTAs and providing science-based regulatory responses. Understanding of QA, regulatory, and clinical functions to guide Preclinical safety assessment and support drug development goals. Ability to synthesize, interpret, and present diverse multidisciplinary data; strong oral and scientific writing communication skills. Ability to navigate, problem-solve, execute, and influence in a dynamic, fast-paced environment. 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. 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 grant 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. About Us
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for kidney diseases and other hard-to-treat diseases. Our proprietary technology enables the design and engineering of precision antibody-based product candidates that specifically bind to and modulate key disease targets. We are developing a robust pipeline of novel therapies for patients with unmet needs. Visterra is a wholly-owned subsidiary of Otsuka America, Inc., a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 125 employees and is located in Waltham, Massachusetts. 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.
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