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Director/Senior Director, Head of DMPK

Belharra TherapeuticsSan Diego, California, United StatesOnsite

WHO WE ARE


Belharra Therapeutics is an early-stage small molecule discovery company founded by pioneers in the field of chemical biology. Through the application of our proprietary chemoproteomics platform merged with innovative biology and medicinal chemistry, we are modulating protein function in previously unidentified ways to push the limits of drug discovery. Our aim is to deliver transformative, first-in-class medicines for patients suffering from the most serious diseases. 

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


  • 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


  • 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


  • 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. 
  • 100% of Target premium coverage for employees; 85% of Target premium coverage for eligible dependents
  • 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.

Pay Scale Range (CA)$180,000—$244,000 USDAt Belharra Therapeutics, Inc. pay ranges are subject to change and are assigned to a job based on its level within the company.  Individual pay within that range can vary for several reasons including skills/capabilities, experience, and available budget.Belharra is committed to being an Equal Opportunity Employer and our policy is to provide equal employment opportunities to all applicants and employees without regard to race, color, creed, religion, sex, sexual orientation, gender identity, marital status, citizenship status, age, national origin, ancestry, disability, veteran status, or any other legally protected status and to affirmatively seek to advance the principles of equal employment opportunity.Privacy Act Notice and Policy Statement

Life at Belharra Therapeutics

Thrive Here & What We Value1. Collaborative and Positive Work Environment2. Unlimited Growth and Learning Opportunities3. Competitive Compensation and Company Ownership4. Excellent Medical, Dental, and Vision Coverage5. Comprehensive Health Insurance Benefits6. Flexible Vacation and Sick Leave Policy7. Generous Paid Time Off (10 annual company holidays + "shutdown" week)8. 401(k) Program with Company Contributions
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