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Associate Director, Translational Biomarkers

Waltham, MA

Company Overview:

Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

We are looking for a highly motivated and independent candidate to join the Translational Biomarker team to work in a fast-paced biotech environment.  This person will be responsible for the development and/or optimization of assays to support preclinical and clinical programs at Dyne. The successful candidate is expected to have hands-on experience in developing DNA, RNA and protein biomarker assays to be used in preclinical and clinical studies. In addition, this person will work with the manager to represent Translational Biomarkers in internal and external meetings.

 

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:

  • Provide scientific and technical leadership to design, develop and/or optimize biomarker assays to measure analytes in different matrices (e.g., plasma, urine, tissues) following FDA guidance
  • Perform data analysis, provide interpretation, and maintain well-documented lab notebook
  • Evaluate assay performance and troubleshoot issues as they arise
  • Transfer biomarker assays to CROs, and oversee validation
  • Collaborate with relevant departments to execute on the translational biomarker strategy to support Dyne’s clinical programs
  • Setup and maintain lab instrumentation
  • Create, review and/or edit high quality documents with biomarker content
  • Track progress against project timelines, generate regular status updates, and communicate progress and issues to management
  • Multi-task across several projects and manage time effectively with input from manager to achieve results
  • Represent Translational Biomarkers as Biomarker lead at program team meetings

 

Education and Skills Requirements:

  • PhD in biology/biochemistry with at least 8-10 years of experience in the pharmaceutical industry designing clinical biomarker assays
  • Broad, and in-depth knowledge of regulatory biomarker guidance to industry
  • Hands-on assay development experience with different assay formats and detection methods for DNA, RNA and proteins is required
  • Strong assay troubleshooting, data analysis and interpretation skills
  • Experience in transferring assays to CROs
  • Excellent verbal and written communication skills
  • Ability to work collaboratively in a team-oriented environment
  • Strong attention to detail, organizational skills, and ability to multitask
  • Demonstrated ability to troubleshoot and solve problems

#LI-Onsite

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.

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