Senior Director, Translational Biomarkers

The Senior Director, Translational Biomarkers supports the development of all programs currently in early development working collaboratively with cross-functional team members. This role is responsible for designing and building 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 and correlates of protection to enable later-stage development. This position works collaboratively across with other therapeutic areas and research teams to ensure the planning, execution, and delivery of the strategy for clinical trials conducted.

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 programs
• Partner closely with cross-functional experts in Research, Non-Clinical/Pre-Clinical, Clinical Biomarkers, Biostatistics, Bioinformatics, Regulatory, and external partners

Education and Skills Requirements:

• M.D. or Ph.D. required with at least 7 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 neutralizing antibodies), flow cytometry, transcriptomics, sequencing, and diagnostic assays
• Experience in clinical translational or biomarker work and its role across drug development from the early phase through licensure
• Solid experience in the application of biomarkers during the development of assets is preferred, including experience with clinical translational research