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 Twitter, LinkedIn and Facebook.
The Translational Biomarker Lead will be a highly motivated scientist working in a dynamic, cross-functional environment within the clinical development team to implement biomarker strategies for Dyne Therapeutics portfolio. The successful candidate will be a strategic, hands-on scientist who supports all aspects of biomarker development and execution, including patient selection, pharmacodynamic, and clinical response biomarkers. The candidate will utilize internal and external interactions to support clinical biomarker utilization and contribute towards the successful development and execution of the biomarker plan for a given program. This position will report to the head of Translational Biomarkers at Dyne Therapeutics.
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:
- Design and develop biomarker strategies for patient selection and pharmacodynamic assessment of drug candidates
- Ensure timely execution of biomarker assays, delivery of data and interpretation in support of clinical trials
- Drawing on knowledge of disease biology and mechanism-of-action of Dyne drug candidates, identify novel patient selection and PD biomarker candidates
- Identify platforms and manage vendors for biomarker assay qualification and execution
- Explore and leverage new biomarker technologies and expand Dyne biomarker research capability to support the pipeline
- Build and manage relationships and collaborations with KOLs and CROs
- Collaborate with Clinical, Clinical Operations, Regulatory, and Discovery colleagues to ensure impactful execution of clinical biomarker strategies
- Serve as Translational Biomarker Lead on program teams and be a key contributor to the overall program strategy and author for all relevant regulatory documents
- Contribute to an innovative, science-driven, and highly collaborative culture both within the group and across all functions
Education and Skills Requirements:
- PhD or MS in Biochemistry, Immunology, Molecular Biology or relevant field
- 5-10 years of industry experience in clinical biomarker, especially in supporting early clinical development
- Significant experience taking biomarker assays from discovery phase to assay validation and clinical trial implementation for multiple programs
- Strong scientific background in clinical bioanalytical assay development and validation. Direct experience in common platforms including next-generation sequencing, flow/mass cytometry, immunoassay, and quantitative PCR
- Highly collaborative and effective in working with discovery and clinical development colleagues
- Excellent communication skills, ability to influence and inspire in multidisciplinary team settings
- Extensive experience working with CROs and strong timeline management skills
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.