Invivyd
Director, Pre-Clinical Development
Invivyd, Newton, Massachusetts, United States, 02165
ABOUT US
There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.
At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).
Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.
This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.
Be part of making a difference. Be part of Invivyd.
In this role you will be responsible for executing the Invivyd preclinical development strategy in support of regulatory filings and clinical programs. This position will work collaboratively across research and clinical teams to ensure planning, execution, and delivery of the strategy for preclinical candidates.
Responsibilities:
Lead strategy and execution of preclinical drug development programs from pre-IND through EUA
Design and execute overall DMPK and preclinical translation strategy for Invivyd pipeline
Develop experimental designs to evaluate potential immune correlates of protection for disease treatment or prevention
Plan, execute, and report all preclinical studies
CRO selection and oversight of CROs to ensure appropriate/timely initiation, progression, and completion of preclinical studies per project timelines
Study and data interpretation, document authoring, regulatory writing, and interactions
Develop and oversee preclinical program budgets
Generate, analyze, and present data, both orally and as written reports; deliver presentations internally or externally as needed
Develop and provide input and recommendations into all study related documentation (including initial study protocol and amendments) and processes
Requires close partnership with cross-functional experts in Research, Non-Clinical Science, Clinical, Biostatistics, Regulatory, and external partners
Requirements:
Ph.D. with 7-10 years of pharmaceutical or biotechnology experience, including antibody drug development
Expertise in technical, scientific, and regulatory aspects of preclinical safety and efficacy evaluation of antibody therapies in infectious disease
Proven ability to design, manage and interpret outsourced preclinical studies
Previous experience in progressing biologics through preclinical development to IND
Experience in clinical translational work and its role across drug development from early phase through authorization
Experience interacting with worldwide regulatory agencies and authoring regulatory filings
At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.
Invivyd is proud to be an equal opportunity employer.
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There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.
At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering, designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs).
Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.
This is your chance to be part of the company with the first mAb authorized in over a year and the only one currently on the market for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise.
Be part of making a difference. Be part of Invivyd.
In this role you will be responsible for executing the Invivyd preclinical development strategy in support of regulatory filings and clinical programs. This position will work collaboratively across research and clinical teams to ensure planning, execution, and delivery of the strategy for preclinical candidates.
Responsibilities:
Lead strategy and execution of preclinical drug development programs from pre-IND through EUA
Design and execute overall DMPK and preclinical translation strategy for Invivyd pipeline
Develop experimental designs to evaluate potential immune correlates of protection for disease treatment or prevention
Plan, execute, and report all preclinical studies
CRO selection and oversight of CROs to ensure appropriate/timely initiation, progression, and completion of preclinical studies per project timelines
Study and data interpretation, document authoring, regulatory writing, and interactions
Develop and oversee preclinical program budgets
Generate, analyze, and present data, both orally and as written reports; deliver presentations internally or externally as needed
Develop and provide input and recommendations into all study related documentation (including initial study protocol and amendments) and processes
Requires close partnership with cross-functional experts in Research, Non-Clinical Science, Clinical, Biostatistics, Regulatory, and external partners
Requirements:
Ph.D. with 7-10 years of pharmaceutical or biotechnology experience, including antibody drug development
Expertise in technical, scientific, and regulatory aspects of preclinical safety and efficacy evaluation of antibody therapies in infectious disease
Proven ability to design, manage and interpret outsourced preclinical studies
Previous experience in progressing biologics through preclinical development to IND
Experience in clinical translational work and its role across drug development from early phase through authorization
Experience interacting with worldwide regulatory agencies and authoring regulatory filings
At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.
Invivyd is proud to be an equal opportunity employer.
#J-18808-Ljbffr