Director/Senior Director, Head of DMPK

Company: Belharra Therapeutics, Inc.
Location: San Diego
Posted on: November 13, 2024

Job Description:

WHAT WE ARE LOOKING FOR
Reporting to the Senior Vice President, Chemistry, we are seeking a highly engaged and experienced Director/Senior Director, Head of DMPK to join our multidisciplinary drug discovery team in developing novel therapeutics to treat unmet medical needs. This role is responsible for leading DMPK and formulation research activities to support drug discovery programs at all stages (lead optimization, pre-IND, clinical). This includes managing DMPK and formulation resources, interpreting data and providing timely DMPK-related support to the broader research team(s). This includes, but may not be limited to, discovery chemistry, biology, preclinical pharmacology, and toxicology as well as clinical pharmacology. The role works cross-functionally with internal groups and project teams and external CROs.
WHAT YOU'LL BE RESPONSIBLE FOR

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• Design and execute in vitro and in vivo preclinical studies to understand the pharmacokinetics of drug candidates
  
• Manage experiments at CROs from conception through final report, including protocol development, budget, timeline, sample handling/processing, and PK data analysis/interpretation
  
• Collaborate closely with the chemistry, biology and pharmacology teams to drive programs forward (from early stages through clinical studies)
  
• Represent the DMPK/formulation functions at company meetings (i.e. project, research leadership meetings)
  
• Prepare documentations intended for regulatory submissions, including the relevant sections of IBs and INDs
  
• Assess and recommend doses/regimens for both in vivo animal efficacy and first-in-man (FIH) studies
  
• Perform all duties in keeping with the Company's core values, policies, and all applicable regulations
  
• May manage, coach and mentor direct reports
  
  WHAT YOU'LL BRING TO THE TEAM
  
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  • PhD in Drug Metabolism, Pharmacokinetics, Chemistry, or related scientific discipline with a minimum of 10 years of biotech/pharmaceutical drug discovery and development experience
    
  • Ability to provide functional area DMPK/formulation support to progress compounds through lead optimization into the clinic
    
  • Familiarity and hands-on experience with all aspects of small molecule drug development DMPK and ADME topics from lead optimization through to filing an IND and supporting early Phase 1 clinical studies
    
  • Track record of contributions to the relevant sections of IND filings
    
  • Excellent hands-on knowledge with PK/PD software and programming skills (e.g., Phoenix WinNonlin, Phoenix NLME, NONMEM, R/S-Plus, MATLAB, SAS, XPose, WinBUGS, MONOLIX, and Gastroplus)
    
  • Strong experience with in vitro and in vivo ADME studies
    
  • Management experience of external DMPK/formulation resources
    
  • Demonstrated strong leadership; and the ability to influence and make decisions
    
  • Excellent collaborative verbal and written communication skills
    
  • Able to work well with cross-functional teams
    
  • Meticulous attention to detail with strong reasoning and problem-solving skills in experimental design, data analysis, and interpretation
    
  • Ability to manage multiple projects in a fast-paced environment
    
    WHAT YOU'LL GET AS PART OF OUR TEAM
    
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    • A collaborative, fun, and positive culture.
      
    • Limitless growth and learning opportunities.
      
    • A chance to make a lasting impact on drug discovery and human health.
      
    • Competitive compensation and company ownership.
      
    • Excellent Medical, Dental and Vision coverage from a broad choice of providers and plans.
      
    • 401(k) program with a company sponsored contribution.
      
    • "Take what you need" vacation and sick leave policy.
      
    • 10 annual paid company holidays, plus a "shutdown" the last week of December.
      
    • The lifestyle of San Diego with an open, vibrant work and lab space with flexibility and autonomy to do your work how and where you need.
      
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Keywords: Belharra Therapeutics, Inc., Moreno Valley , Director/Senior Director, Head of DMPK, Executive , San Diego, California