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Director, DMPK

Company: Nested Therapeutics
Location: Cambridge
Posted on: November 24, 2022

Job Description:

Director / Senior Director - DMPKNested Therapeutics, Cambridge, MA Nested Therapeutics (www.nestedtx.com) is a Cambridge-based biotech focused on discovering and developing the next generation of small molecule precision medicines. We are advancing drug discovery programs based on a platform that combines insights in cancer genomics, structural biophysics and chemical biology. Our lead programs target novel and differentiated mechanisms for pathways comprising the heartland of cancer research, and we are developing our platform to establish a robust target discovery engine.
We are seeking a highly motivated and enthusiastic scientific leader with expertise in DMPK. The candidate will lead the DMPK function and will have the opportunity to contribute to both drug discovery and clinical projects in an innovative and fast-paced team environment with tremendous growth opportunities. (S)he will be responsible for the development and execution of integrated preclinical DMPK, PK/PD and human PK/dose prediction strategies from target assessment through early clinical development, overseeing DMPK studies, providing data analysis and interpretation in preparation for final reports, ensuring regulatory submission and compliance. This position is expected to represent DMPK functions in a multidisciplinary team to support the conduct of pre-clinical studies, bring discovery candidates into development, and prepare documents for regulatory submission.
Responsibilities:

  • Accountable for design and execution of all nonclinical aspects of all development programs from early research to early clinical development
  • Responsible for key first-in-human enabling DMPK studies.
  • Elaborate, establish, and implement DMPK optimization strategies with respect to understanding the PK/PD relationship, obtaining appropriate exposure in preclinical species for safety testing, minimizing potential safety liabilities and support human PK and dose predictions
  • Manage, analyze, review, summarize, interpret and report results of DMPK studies
  • Oversee and manage studies with CROs and consultants
  • Prepare summary reports for regulatory submissions; and assist in the preparation of DMPK, BioAnalytical sections for Investigational New Drugs (INDs), annual reports, Investor Brochures (IBs) and New Drug Applications (NDAs)
  • Serve as DMPK expert on internal project teams, participate in generating written responses to inquires received from regulatory agencies, and prepare peer-reviewed scientific publications
    Qualifications:
    • A Ph.D. or equivalent degree in pharmaceutical sciences or other relevant bioscience discipline
    • 10+ years of industry related experience in drug research & development
    • Experience in small molecules is required, experience with small molecule protein degraders is a plus
    • Proven experience to work as project leader in cross-functional teams
    • Proven success with development of oncology assets is preferred
    • Knowledgeable of the mechanisms of small molecule disposition
    • Experience with advanced PK and PK/PD modeling software preferred
    • Experience in overseeing collaborations with external toxicology consultants preferred
    • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical assessment packages to support first in human studies
    • Demonstrated, active network with research centers, CROs, consultants and key opinion leaders
    • Excellent communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, and board meetings

      Interested Candidates should forward a cover letter and CV to careers@nestedtx.com

Keywords: Nested Therapeutics, Cambridge , Director, DMPK, Executive , Cambridge, Massachusetts

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