Director, ADME-PK
Department: 104 Non-ClinicalLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is a clinical-stage muscle disease company focused on 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 has a broad portfolio of programs for serious muscle diseases, including candidates 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.
Role Summary:
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 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:
- Represent PCD as subject matter expert (SME) providing expertise and guidance on ADME-PK on discovery and program teams
- Design and oversee internal/external PCD ADME-PK studies to understand ADME-PK properties of Fab-oligonucleotide conjugate therapeutics
- The primary contact to manage, guide, and execute these studies in CROs, ensuring studies are completed to meet program objectives and timeline, and with the quality consistent with regulatory standards and guidelines (FDA, EMA, GLP, and GCP)
- Responsible for the analysis, interpretation, integration, and reporting of ADME-PK data generated both internally and externally
- Author high quality regulatory documents
- Facilitate strategic scientific communication via meetings, abstracts and manuscripts
- Partner with and support Research, Toxicology, Translational Biomarkers, Clinical, Regulatory, Project Management and other departments
Education and Skill Requirements:
- PhD in pharmaceutical sciences, pharmacokinetics, or a related discipline with a minimum of 5 years experience working in the pharmaceutical industry
- Broad and in-depth knowledge in ADME-PK and bioanalytical method development of biopharmaceuticals and / or oligonucleotides
- Hands-on skills in using Phoenix/WinNonlin for interpreting PK data
- Other aspects, comprising strong interpersonal and collaboration skills, familiarity with regulatory submission including FIH dosing strategy, understanding of GLP requirements, and enjoying the collaborative and dynamic biotech setting, are also desirable
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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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