Senior Director Translational Biomarkers

Location

Waltham, MA | United States

Job description

Job description

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:

• 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

Education and Skills Requirements:

• 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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Salary

$35k - $71.25k