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 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.
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.