Dyne Tx
Senior Director, Toxicology
Dyne Tx, Waltham, Massachusetts, United States, 02254
Our commitment to people with muscle diseasesDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit
Dyne Therapeutics .Role Summary:The Senior Director, Toxicology is a key member of preclinical development teams and is responsible for the strategic planning and execution of nonclinical safety plans of Dyne’s portfolio programs supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational therapeutics consisting of targeting antibodies conjugated with a variety of oligonucleotide and protein payloads to treat serious neuromuscular diseases. The person in this role must possess an in-depth understanding of regulatory guidance as they pertain to the nonclinical development of novel therapeutics along with documented experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required. This individual should have experience in the nonclinical safety assessment of therapeutic antibodies and/or oligonucleotides. The ability to work collaboratively with cross-functional teams is critical for this position.This role is based in Waltham, MA without the possibility of being a remote role.Primary Responsibilities Include:Represent Preclinical Development (PCD) on program teams, providing expertise and guidance in regulatory toxicologyDesign and execute nonclinical safety plans for Dyne candidate therapeuticsPrincipal contact to external CROs executing these studies, ensuring studies are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO and GLP)Responsible for interpreting toxicology data and communicating results to program teams and senior managementResponsible for writing appropriate content and submission-ready documentation for the toxicology components of regulatory submissionsLead issue-resolution teams, driving the science for investigative and discovery toxicology as neededParticipate in the design and expansion of Dyne’sEducation and Skills Requirements:PhD and post-doctoral training in toxicology or a related field and/or DVMRelevant board certification in toxicology and/or Veterinary Pathology8+ years of experience in nonclinical development experience in a biotech or pharmaceutical setting including direct experience in preparation of toxicology components of regulatory submissionsExperience in development of toxicology study package to ensure compliance with regulationsExperience designing and managing studies at contract research organizationsExperience writing and interpreting toxicology data, including the development of final reportsExperience in development of new supportive technologies or toxicological approachesExperience assessing toxicity of antibody-drug conjugates is a plusExpertise in immunology or immunotoxicology is a plusExperience in people management is a plusStrong written and oral communication, organization and multitasking skillsAbility to work in a highly collaborative and cross-functional research environment including managing project timelines to meet corporate goalsFlexibility to function well within a team environment and within condensed timelinesAbility to verbalize complex study issues and demonstrated problem-solving abilityDyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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Dyne Therapeutics .Role Summary:The Senior Director, Toxicology is a key member of preclinical development teams and is responsible for the strategic planning and execution of nonclinical safety plans of Dyne’s portfolio programs supporting late discovery through first-in-human and proof-of-concept clinical studies of investigational therapeutics consisting of targeting antibodies conjugated with a variety of oligonucleotide and protein payloads to treat serious neuromuscular diseases. The person in this role must possess an in-depth understanding of regulatory guidance as they pertain to the nonclinical development of novel therapeutics along with documented experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies. Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is required. This individual should have experience in the nonclinical safety assessment of therapeutic antibodies and/or oligonucleotides. The ability to work collaboratively with cross-functional teams is critical for this position.This role is based in Waltham, MA without the possibility of being a remote role.Primary Responsibilities Include:Represent Preclinical Development (PCD) on program teams, providing expertise and guidance in regulatory toxicologyDesign and execute nonclinical safety plans for Dyne candidate therapeuticsPrincipal contact to external CROs executing these studies, ensuring studies are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO and GLP)Responsible for interpreting toxicology data and communicating results to program teams and senior managementResponsible for writing appropriate content and submission-ready documentation for the toxicology components of regulatory submissionsLead issue-resolution teams, driving the science for investigative and discovery toxicology as neededParticipate in the design and expansion of Dyne’sEducation and Skills Requirements:PhD and post-doctoral training in toxicology or a related field and/or DVMRelevant board certification in toxicology and/or Veterinary Pathology8+ years of experience in nonclinical development experience in a biotech or pharmaceutical setting including direct experience in preparation of toxicology components of regulatory submissionsExperience in development of toxicology study package to ensure compliance with regulationsExperience designing and managing studies at contract research organizationsExperience writing and interpreting toxicology data, including the development of final reportsExperience in development of new supportive technologies or toxicological approachesExperience assessing toxicity of antibody-drug conjugates is a plusExpertise in immunology or immunotoxicology is a plusExperience in people management is a plusStrong written and oral communication, organization and multitasking skillsAbility to work in a highly collaborative and cross-functional research environment including managing project timelines to meet corporate goalsFlexibility to function well within a team environment and within condensed timelinesAbility to verbalize complex study issues and demonstrated problem-solving abilityDyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
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