Director, Preclinical Development
6 days ago
Waltham
Job DescriptionSalary: Director, Preclinical Development The Opportunity The Director, Preclinical Development 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 (i.e. IND, CTA). The Director, reporting to the Executive Director of Preclinical Development, will collaborate with Research teams making the Research to Development transition through candidate screening, hit to lead, and final candidate nomination. This includes directing non-regulated pharmacokinetic and pharmacodynamic studies in relevant species and development and execution of the Preclinical in vitro and in vivo safety strategy, including GLP toxicology studies, to enable first in human studies. The Director will work closely in collaboration with the Pharmaceutical Sciences and Technology (i.e. CMC) to ensure test article supply for both non-GLP and GLP studies. The Director will work closely in collaboration with the Bioanalytical teams to ensure complete package spanning PK/PD/ADA assessments for non-GLP and GLP studies. The Director, Preclinical Development will be responsible for soliciting requests for proposals, scope of work quotations, CRO selection, contract negotiation, study protocol generation, study execution, and final study report. The Director will support programs from the R to D transition through general GLP toxicology and safety pharmacology studies to enable first in human safety studies, chronic toxicology studies to enable proof of concept studies in patients, and in collaboration with Otsuka Pharmaceuticals Preclinical partners, later stage Preclinical studies assessing safety in development and reproductive toxicology studies to support BLA. Visterra is seeking a flexible candidate with a broad-based knowledge of immunology and biologics drug development. The primary focus is preclinical studies to support IND filings balancing long-term strategy with tactical and detailed technical decision-making and project management. This individual is responsible for technical oversight, outsourcing, technology transfer and documentation for in vivo studies and supporting bioanalytical methods. The individual will actively participate in program teams, as well as collaborate effectively across functions. The successful candidate will demonstrate a proven track record in development and have experience with biologics and FDA/EMA guidelines. This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards. Responsibilities • Develops preclinical program strategies for drug development candidates making the transition from Research to Development., • Identifies relevant species for pharmacology and toxicology assessment to programs based on target cross-reactivity., • Responsible for conduct of in vitro and in vivo preclinical studies to inform safety liabilities for lead candidate, • Authors PK/PD and safety reports summarizing Preclinical work and works with Regulatory Affairs to provide Preclinical support during regulatory interactions., • Responsible for the scientific oversight of preclinical study execution and review of preclinical data., • Prepares RFPs. defines study designs for SOWs, negotiates contracts and selects and oversees CROs responsible for preclinical safety/PK/PD assessments., • Participates in cross functional team meetings, presents and summarizes preclinical study data and work closely with Program Management to ensure timeline and deliverable alignment, • Collaborates with clinical and translational teams to ensure preclinical strategy aligns with the clinical development plan and provides sufficient safety margins for the intended dose, frequency and route of administration required for clinical studies., • Provides scientific strategic input and oversees development of preclinical study protocols., • Contributes to the authoring and revision of regulatory submissions, including overseeing module 2 content for INDs, • Works closely with internal teams to accumulate scientific knowledge necessary to support drug development goals., • Prepares and presents scientific material for conference presentations or publications, • Able to support programs at different stages of development., • Responsibilities span from CRO selection, contract oversight, vendor management and data analysis., • Oversees completion of key program goals and deliverables related to preclinical development., • Demonstrates a strong ability to effectively communicate., • Proven 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 an emphasis on preclinical safety., • Previous experience with biologics and monoclonal antibodies highly desirable., • Experience in outsourcing, vendor management, and interfacing with internal groups, establishing and managing consultants and CROs driving timely delivery of clear, accurate, and well-written Preclinical study reports., • Experience running GLP Toxicology studies required., • Experience representing Preclinical on early stage cross-functional development teams collaborating with representatives from Research, CMC, RA, and Clinical to define the product development plan and communicate Preclinical activities and results to ensure program is well-positioned to initiate clinical investigations., • Proven track record of demonstrating the ability to work effectively in a collaborative cross-functional global environment, • Strong knowledge of FDA, EMA, and ICH guidance documents including GLP regulations, • Required experience in authoring Preclinical sections of INDs/CTAs and preparing and presenting science-based responses to regulatory questions., • Deep understanding of QA, regulatory, and clinical functions to guide key Preclinical safety assessment activities, setting up drug candidates for success at all stages of development., • Ability to synthesize, interpret, and present diverse, multidisciplinary data sets., • Ability to think critically, synthesize and extract simple principles from complex datasets, communicate effectively across broad spectrum of both internal and external audiences., • Strong oral and scientific writing communication skills., • Ability to navigate, problem-solve, execute, and influence in a dynamic, fast-paced and evolving environment 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. About Us 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 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.