- Develop experimental and translational medicine study designs to evaluate disease heterogeneity, mechanism of action for disease treatment or prevention
- Develop a biomarker strategy to support clinical development for early-stage clinical programs
- Lead the clinical prioritization of biomarkers for early clinical development programs for early proof-of-concept and late-stage clinical development
- Develop and provide input and recommendations into all study related documentation (including protocol, informed consent form, and amendments) and processes
- Assist in the selection of clinical diagnostic biomarkers and explore new technologies through collaboration and partnerships, internal and external
- Evaluate technologies to identify, define and implement clinical biomarker strategies to support the clinical development of Dyne's programs
- Author the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-author, assist and support the development of publications, abstracts, and presentations
- Partner with biostatisticians and computational experts to ensure delivery and interpretation of high-quality data to support internal decision-making and health authority filings
- Partner closely with cross-functional experts in Research, Non-Clinical/Pre-Clinical, Clinical Development, Biostatistics, Bioinformatics, Regulatory, and external partners
- M.D. or Ph.D. required with at least 15 years of experience in the pharmaceutical/biotechnology industry or equivalent government/academic experience
- Experience with rare disease development or related science focus is required
- Experience designing and building clinical development plans preferred
- Thorough understanding of rare muscle diseases, with experience integrating novel endpoints and biomarkers into clinical trials
- Must be familiar with scientific methods including assays (binding and cell based), flow cytometry, transcriptomics, sequencing, and diagnostic assays
- Experience in clinical translational or biomarker work and its role across drug development from early phase through licensure
- Solid experience in the application of biomarkers during development of assets is preferred, including experience with clinical translational research
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Senior Director, Translational Biomarkers - Waltham, United States - BioSpace
Description
Job DetailsCompany Overview:
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 FORCETM 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).
Role Summary:
The Senior Director, Translational Biomarkers supports the development of Dyne's translational strategy for programs currently in late research/early development working collaboratively with cross functional team members. This role is responsible for designing and execution of preclinical and clinical development plans in terms of endpoints and biomarkers with a focus on quick win/fail early strategies and early proof of concept. This individual also builds strategies to establish surrogates to enable later stage development. This position works collaboratively across therapeutic areas and research teams to ensure planning, execution, and delivery of the strategy for clinical trials conducted by Dyne.
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:
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.
