BioSpace
Overview
Director, Preclinical Development at BioSpace. 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 (IND/CTA). The Director reports to the Executive Director of Preclinical Development and collaborates with Research, Pharmaceutical Sciences and Technology (CMC), and Bioanalytical teams to ensure a seamless Research-to-Development transition and a complete PK/PD/ADA package for non-GLP and GLP studies. Responsibilities
Develop preclinical program strategies for drug development candidates transitioning from Research to Development. Select relevant species for pharmacology and toxicology assessments based on target cross-reactivity. Oversee in vitro and in vivo preclinical studies to inform safety liabilities for lead candidates. Author PK/PD and safety reports; provide Preclinical support during regulatory interactions with Regulatory Affairs. Provide scientific oversight of preclinical study execution and review of 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 teams, present preclinical data, and coordinate with Program Management on timelines and deliverables. Collaborate with clinical and translational teams to align preclinical strategy with the clinical development plan and ensure safety margins for the planned clinical regimen. Contribute to development of preclinical study protocols and regulatory submissions, including Module 2 content for INDs/CTAs. Coordinate with internal teams to accumulate scientific knowledge supporting drug development goals; prepare and present scientific material for conferences or publications. Support programs at different stages of development; manage CRO selection, contracts, vendor relationships, and data analysis. Communicate effectively across functions and maintain high quality standards; meet deliverables and timelines. Other duties as required. Qualifications
Ph.D. with 5-10 years of industry experience, or BS/MS with 10+ years in biopharmaceutical development, with emphasis on preclinical safety. Experience with biologics and monoclonal antibodies is highly desirable. Experience outsourcing, vendor management, interfacing with internal groups, and driving timely delivery of clear, accurate preclinical study reports. Experience running GLP toxicology studies. Experience representing Preclinical on early-stage cross-functional development teams; ability to define development plans and communicate activities and results to enable clinical investigations. Proven ability to work collaboratively in a global environment. Strong knowledge of FDA, EMA, and ICH guidance, including GLP regulations. Experience authoring preclinical sections of INDs/CTAs and responding to regulatory questions. Understanding of QA, regulatory, and clinical functions to support preclinical safety assessments. Ability to synthesize and present multidisciplinary data; strong written and oral communication skills. Ability to navigate and influence in a dynamic, fast-paced 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 company contribution to premiums. Staff wellness programs, disability programs, life insurance, and flexible spending accounts. Paid time off, holidays, and parental leave; growth in time accrual with tenure. Fitness reimbursement, tuition and student loan reimbursement, and employee discounts. About Us
Visterra is a clinical-stage biotechnology company focused on antibody-based therapies for kidney diseases and other hard-to-treat diseases. Our platform enables the design of precision antibody products to address unmet medical needs. Visterra is a wholly owned subsidiary of Otsuka America, Inc., located in Waltham, MA. We provide equal employment opportunities to all employees and applicants.
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Director, Preclinical Development at BioSpace. 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 (IND/CTA). The Director reports to the Executive Director of Preclinical Development and collaborates with Research, Pharmaceutical Sciences and Technology (CMC), and Bioanalytical teams to ensure a seamless Research-to-Development transition and a complete PK/PD/ADA package for non-GLP and GLP studies. Responsibilities
Develop preclinical program strategies for drug development candidates transitioning from Research to Development. Select relevant species for pharmacology and toxicology assessments based on target cross-reactivity. Oversee in vitro and in vivo preclinical studies to inform safety liabilities for lead candidates. Author PK/PD and safety reports; provide Preclinical support during regulatory interactions with Regulatory Affairs. Provide scientific oversight of preclinical study execution and review of 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 teams, present preclinical data, and coordinate with Program Management on timelines and deliverables. Collaborate with clinical and translational teams to align preclinical strategy with the clinical development plan and ensure safety margins for the planned clinical regimen. Contribute to development of preclinical study protocols and regulatory submissions, including Module 2 content for INDs/CTAs. Coordinate with internal teams to accumulate scientific knowledge supporting drug development goals; prepare and present scientific material for conferences or publications. Support programs at different stages of development; manage CRO selection, contracts, vendor relationships, and data analysis. Communicate effectively across functions and maintain high quality standards; meet deliverables and timelines. Other duties as required. Qualifications
Ph.D. with 5-10 years of industry experience, or BS/MS with 10+ years in biopharmaceutical development, with emphasis on preclinical safety. Experience with biologics and monoclonal antibodies is highly desirable. Experience outsourcing, vendor management, interfacing with internal groups, and driving timely delivery of clear, accurate preclinical study reports. Experience running GLP toxicology studies. Experience representing Preclinical on early-stage cross-functional development teams; ability to define development plans and communicate activities and results to enable clinical investigations. Proven ability to work collaboratively in a global environment. Strong knowledge of FDA, EMA, and ICH guidance, including GLP regulations. Experience authoring preclinical sections of INDs/CTAs and responding to regulatory questions. Understanding of QA, regulatory, and clinical functions to support preclinical safety assessments. Ability to synthesize and present multidisciplinary data; strong written and oral communication skills. Ability to navigate and influence in a dynamic, fast-paced 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 company contribution to premiums. Staff wellness programs, disability programs, life insurance, and flexible spending accounts. Paid time off, holidays, and parental leave; growth in time accrual with tenure. Fitness reimbursement, tuition and student loan reimbursement, and employee discounts. About Us
Visterra is a clinical-stage biotechnology company focused on antibody-based therapies for kidney diseases and other hard-to-treat diseases. Our platform enables the design of precision antibody products to address unmet medical needs. Visterra is a wholly owned subsidiary of Otsuka America, Inc., located in Waltham, MA. We provide equal employment opportunities to all employees and applicants.
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