Dyne 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 seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.
The Director, Toxicology is a key member of preclinical development teams and be 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 antibody oligonucleotide therapeutics to treat serious muscle 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. Additional responsibilities for this role with the appropriate training in veterinary pathology include working with Research colleagues to evaluate in situ effects of lead candidates from pharmacology studies. Experience in nonclinical safety assessment of therapeutic antibodies and/or oligonucleotides is a plus. 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. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
- Represent PCD on program teams, providing expertise and guidance in regulatory toxicology
- Design and execute nonclinical safety plans for Dyne candidate therapeutics
- Principal 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 management
- Responsible for writing appropriate content and submission-ready documentation for the toxicology components of regulatory submissions
- Lead issue-resolution teams, driving the science for investigative and discovery toxicology as needed
- Additionally, pathologists would collaborate with Research colleagues in design of pharmacology / investigative studies to assess in situ effects of candidate molecules
Education and Skill Requirements:
- PhD and post-doctoral training in toxicology or a related field and/or DVM
- Relevant board certification
- 8+ years of experience of nonclinical development experience in a biotech or pharmaceutical setting including direct experience in preparation of toxicology components of regulatory submissions
- Experience in development of toxicology study package to ensure compliance with regulations
- Experience designing and managing studies at contract research organizations
- Experience writing and interpreting toxicology data, including the development of final reports
- Experience in development of new supportive technologies or toxicological approaches
- Experience assessing toxicity of antibody-drug conjugates is a plus
- Expertise in immunology or immunotoxicology is a plus
- Strong written and oral communication, organization and multitasking skills
- Ability to work in a highly collaborative and cross-functional research environment including managing project timelines to meet corporate goals
- Flexibility to function well within a team environment and within condensed timelines
- Ability to verbalize complex study issues and demonstrated problem-solving ability
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne 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.