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 Director, ADME-PK will be a key member of Preclinical Development (PCD) function and be responsible for the strategic planning and execution of in vitro and in vivo pharmacokinetics (PK), absorption, distribution, and elimination (ADME), pharmacokinetics/pharmacodynamics (PK/PD) studies of Dyne’s portfolio programs. These activities will support discovery through first-in-human (FIH) of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. Working closely with Research, Toxicology, Translational Biomarkers and Bioanalytics, Clinical, Regulatory, Project Management and other departments, the successful candidate will be expected to provide expertise in PK and PK/PD study design, protocol development and execution, data analysis, modeling, interpretation, and reporting. The incumbent will apply various approaches and strategies to predict human PK parameters from analysis of nonclinical data and assess PK/PD properties of drug candidates based on preclinical data. The incumbent will author clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures (IB).
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:
Education and Skill Requirements:
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.