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Senior Director, ADME-PK/Clinical Pharmacology

Company: Dyne Therapeutics, Inc.
Location: Waltham
Posted on: September 12, 2020

Job Description:

National Postdoctoral Association Career Center Senior Director, ADME-PK/Clinical Pharmacology

D Senior Director, ADME-PK/Clinical Pharmacology Dyne Therapeutics is a leading muscle disease company focused on advancing innovative life-transforming therapeutics for patients with genetically driven diseases. We are utilizing our proprietary FORCE platform to overcome the current limitations of muscle tissue delivery and advance modern oligonucleotide therapeutics for muscle diseases. Dyne was founded in 2017 by Atlas Ventures and is headquartered in Waltham, MA. For more information, please visit www.dyne-tx.com .

Role:

Reporting to the Vice President, Head of Preclinical Development, the Senior Director, ADME-PK/Clinical Pharmacology will be a leading member of the Preclinical Development team. This individual will be a key member of the development team and be responsible for the strategic planning and execution of ADME-PK/clinical pharmacology efforts from late discovery through first-in-human and proof-of-concept clinical studies of investigational antibody oligonucleotide therapeutics to treat serious muscle diseases. The candidate will also be responsible for non-clinical and clinical pharmacokinetic and pharmacodynamic activities that support compounds as they move through early clinical development. By working closely with the Translational Biomarker lead, the candidate will ensure required assays and appropriate processes are transferred to Contract Research Organizations (CROs) to meet program timelines. The ideal candidate should have documented experience utilizing PK/PD modeling to advance antibodies and oligonucleotide therapeutics into the clinic. The ability to work collaboratively with cross-functional teams is critical for this position.

Primary Responsibilities Include:

Ensure quality and timely submission of all ADME-PK/clinical pharmacology-related documents and materials for regulatory filings and interactions

Responsible for overall execution of PK/PD plans including designing ADME-PK, biodistribution and clinical pharmacology strategies for Dyne candidate therapeutics

Collaborate with discovery/preclinical scientists, translational biomarker colleagues, and clinical scientist/medical director for development of the clinical pharmacology plan

Propose PK/PD endpoints appropriate for programmatic advancement decisions, ensure proper sampling in clinical protocol, and work with translational biomarker lead to identify and develop appropriate assays as well as platform and program specific investigations

Analyze data and communicate results regarding biological fate of administered therapies during clinical development

Ensure that studies and assay sample analyses are conducted in line with the appropriate quality and regulatory standards and guidelines (FDA, CHMP, WHO, GLP, and ISO).

Requirements

Education and Skill Requirements:

Strong written and oral communication, organization and multitasking skills; with the ability to work in a highly collaborative and cross-functional research environment including managing project timelines to meet corporate goals

MD, PhD or PharmD and post-doctoral training in a field related to ADME-PK, Clinical Pharmacology, Translational Pharmacology or related field

10+ years of experience in a translational development-related position(s) in a biotech or pharmaceutical setting

Understanding of pre-clinical, translational, and clinical drug development

Experience in measuring and/or modeling drug disposition

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.

Job Information

Job ID: 54563668

Location:

Waltham, Massachusetts, United States

Position Title: Senior Director, ADME-PK/Clinical Pharmacology

Company Name: Dyne Therapeutics, Inc.

Job Function: Pharmacology

Job Type: Full-Time

Job Duration: Indefinite

Min Education: Ph.D.

Min Experience: Over 10 Years

Required Travel: 0-10%

View your connections at Dyne Therapeutics, Inc. LinkedIn Jobs You May Like D

Dyne Therapeutics, Inc.

Waltham, Massachusetts, United States

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Dyne Therapeutics, Inc.

Waltham, Massachusetts, United States

15800 Crabbs Branch Way, Rockville, Maryland 20855 (301) 984-4800

Keywords: Dyne Therapeutics, Inc., Waltham , Senior Director, ADME-PK/Clinical Pharmacology, Other , Waltham, Massachusetts

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