/ Accent Therapeutics hiring Director, DMPK in Lexington, MA, US

Director, DMPK

Accent Therapeutics

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 12/28/2020
  • Website: accenttx.com
  • Company Address: 65 Hayden Ave, Lexington, Massachusetts 02421, US

About Accent Therapeutics

Founded in 2017, Accent is a biopharmaceutical company developing oncology-focused small molecule therapies in the field of epitranscriptomics. Epitranscriptomics is an emergent area of biology relating to post-transcriptional modifications of RNA that provide cells a unique mechanism to regulate proteins critical for cellular growth and differentiation.

Job Description

Reporting to the VP of Chemistry, the Director of Drug Metabolism and Pharmacokinetics (DMPK) will bring extensive experience in ADME and DMPK to strengthen the discovery and development program teams at Accent. She or he will be responsible for comprehensive DMPK support, including design, execution and interpretation of all DMPK studies, PK/PD modelling, collaboration with colleagues on non-clinical toxicology and translational studies of all discovery and development programs.  As a core member of the program teams, she or he will devise, drive and implement strategies and analyses which will support all aspects of the optimization and promote progression of our oncology-focused small molecule therapies.

Responsibilities

  • Serve as the DMPK lead within the research department;
  • Identify critical ADME/DMPK needs and strategies;
  • Act as a DMPK representative to ensure effective application and integration of ADME, PK and PK/PD studies in support of discovery and development programs;
  • Work with development teams to support human ADME, human PK, dose projections and DDI studies;
  • Deliver and communicate results to project teams to enable decision making;
  • Manage interactions with external CROs to ensure high quality and on-time execution of DMPK studies;
  • Maintain complete and timely data archiving;
  • Write and review relevant sections of regulatory documents

Requirements

  • PhD., Pharm. D. or equivalent training in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related disciplines, with 10 years of relevant experience in the bio/pharmaceutical industry or relevant CROs;
  • In-depth understanding and strategic application of in vitro and in vivo ADME assays, methods and models;
  • Direct hands-on experience and troubleshooting skills in in vitro and in vivo DMPK studies, including PK and PK/PD analyses, quantitative and qualitative LC-MS analysis, in vitro and in vivo biotransformation and human PK and drug interaction predictions is a plus;
  • Expertise in managing CROs and sound knowledge of regulatory guidelines on bioanalysis, GLP practice and DDIs;
  • Proficiency in Phoenix WinNonlin (classic WNL and PHX Model), or similar systems;
  • Ability to develop user-specified mathematical models highly desired;
  • Strong analytical, organizational and communication skills, and a consummate team player

Position:  Full-Time, Exempt

Accent values diversity and is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, marital or veteran status, genetic information, sexual orientation or any other legally protected status. Accent will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.