Our commitment to people with muscle diseases
is our greatest strength

Head of Biomarkers

Department: 120 Clinical Development

Location: Waltham, MA

Company Overview:

Dyne Therapeutics is building a leading muscle disease company dedicated to 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’s broad portfolio of therapeutic candidates for serious muscle diseases includes programs 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 TwitterLinkedIn and Facebook.

Role Summary

The Head of Biomarkers will lead the bioanalytical lab and clinical lab operations that work on our programs to develop robust target liability assessment, pharmacology and toxicology (in vitro and in vivo), and translational biomarker data that allows accelerated transition from the bench to the clinic, from discovery through IND, late-stage clinical development and licensure. This position will work very closely with other cross functional groups including the research, CMC and clinical development organization, all working towards the overall mission of providing transformative therapies to our patients. This role requires the writing and reviewing of preclinical and clinical biomarker sections in regulatory documents, including INDs, MAAs, and BLAs. Success in the role will depend on collaboration across the organization and external vendors to develop and implement processes and standards and to develop regulatory filings. Alignment of the conduct and reporting of bioanalytical testing with Good Clinical Practice (GCP) as well as FDA, EMA, ICH and all other applicable regulatory requirements is also a critical function of the role.

Primary Responsibilities Include:

  • Design, drive, and execute on biomarker strategies in partnership with research and clinical development teams
  • Work with Research to develop, validate, and execute on bioanalytical assays to support predictive, PK/PD, and immunogenicity endpoints in preclinical and clinical development
  • Manage studies working closely with CROs and program/project teams to deliver biomarker data to support programs including: 1) Measuring target engagement to inform clinical decisions for selecting therapeutically relevant doses and schedules. 2) Understanding key pathway interactions and feedback mechanisms to guide rational drug combinations. 3) Generating biomarker data to guide indication selection and identification of targeted patient populations. 4) Defining mechanisms of resistance to treatment
  • Interface with internal functions and external companies to provide technical guidance in the development of biomarker assays and IVDs as needed
  • Ensure complex clinical assays developed and validated internally or externally are fit for purpose
  • Lead the evaluation, validation and implementation of novel technologies and capabilities both internally as well as at CROs or external collaborators
  • Perform analysis of data and summarize results from experiments performed
  • Present key results at group meetings and to project teams, governance bodies and stake-holders
  • Contribute to and ensure the quality of clinical biomarker study reports, data reviews and interpretations, presentations, scientific publications and recommendations to program/project teams and leadership
  • Actively contribute to the optimization of existing as well as the development of new processes to ensure best practice
  • Support cross functional teams with analysis of biomarker data and contribute to internal and external scientific correlative analysis discussions
  • Provide scientific guidance on the assay type to be deployed, frequency of testing, sample matrix, clinical protocol language, and laboratory manuals
  • Review study data on an on-going basis and prepare data presentations for updates to cross-functional teams
  • Review and approve bioanalytical protocols, reports, and related documentation
  • Author and review study reports, biomarker sections of clinical protocols, and documentation required for regulatory submissions including INDs, BLAs, and MAAs

Education and Skill Requirements:

  • PhD 5+ years of relevant experience or MSc with 10+ years of relevant experience within the biopharmaceutical industry
  • Strong scientific background in a relevant field (Biology, Biochemistry, Immunology, other)
  • Direct or indirect experience with assays such as multiplex flo, MSD, ELISA, qPCR, IL-2 independent growth assay, etc.
  • Experience working with CRO partners with a special emphasis on qualification of vendors, technology transfer of in-house assays, vendor management from quality, capability, data flow, interpretation, and reporting perspectives for clinical trial samples
  • Experience across all phases of drug development
  • Extensive knowledge of assay development, qualification, and validation of bioanalytical and biomarker assays under FDA, EMA, ICH GCP/GLP and other applicable guidelines
  • Experience in development of clinical bioassays, e.g., biomarkers, PD, PK, ADA
  • Experience in authoring and critically reviewing technical documents, study protocols and reports related to assay development, validation, and clinical sample testing
  • Experience writing and reviewing biomarker sections of study reports and regulatory documents (IND, BLA, MAA)
  • Management experience
  • Demonstrated ability to manage multiple complex projects and programs simultaneously
  • Excellent attention to details, critical thinking, and data interpretation
  • Strong communication (oral and written) and interpersonal skills
  • Excellent organizational, multi-tasking and collaboration abilities

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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