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Director, DMPK

Company: Eikon Therapeutics
Location: New York
Posted on: September 25, 2022

Job Description:

Company DescriptionEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.PositionThe Director of DMPK will establish and build Eikon's DMPK function, provide technical and scientific leadership to the execution of in vitro and in vivo ADME studies to support programs through preclinical optimization, IND enabling and early clinical stages. This position will report to the Vice President of PharmacologyAbout YouYou're a DMPK expert and leader who loves to solve difficult problems and are not discouraged by challenges. You're a hands-on project manager who thrives in a fast-paced, dynamic environment. You're well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and make judicious decisions. You're collaborative by nature with uncompromising integrity. You're conscientious and with great attention to detail, documentation and organization are second nature. You are excited about being a foundational member of a rapidly growing team.What You'll Do

  • Represent DMPK as the technical and scientific expert on project teams, providing scientific, and strategic leadership, ensuring effective application and integration of ADME studies
  • Design and execute in vitro and in vivo non-clinical ADME studies to understand the properties of novel chemical entities and allow optimization prior to candidate selection
    • Selection and management of external CROs to perform required ADME studies (pre-clinical and IND enabling) including protocol development, budget, timelines, project commencement, data analysis/interpretation and report writing
    • Build an in-house DMPK team of scientists to support selected in-house assays. Supervise and mentor in-house DMPK and bioanalytical scientists to design and execute experiments and report data to the project teams
      • Work in close collaboration with interdisciplinary drug discovery teams, including chemistry, pharmacology, formulations, toxicology and early clinical groups
      • Provide expertise in human PK and efficacious dose prediction of drug candidate molecules using a variety of modelling approaches
      • Authoring of high-quality study reports and regulatory documents including IND sections and clinical documents etc.Qualifications
        • Chemistry, Biological Sciences, Pharmacology or related discipline with at least 10+ years of industrial experience in Drug Discovery and Development in DMPK, PK/PD and ADME
        • Strong track record of drug discovery experience, success and leadership, exemplified by advancement of programs through all stages of discovery to IND filing
        • In depth understanding of the experimental DMPK methodologies and approaches, both in vitro and in vivo
        • In-depth knowledge of FDA and ICH guidelines, including experience in the preparation of regulatory documents and knowledge of regulatory guidance in relation to DMPK activities
        • Hands-on experience in in vitro ADME assays, quantitative and qualitative LC-MS analysis, in vitro and in vivo biotransformation, and human PK and drug interaction predictions.
        • Strong written and interpersonal communication skillsEikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization.You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.

Keywords: Eikon Therapeutics, New York , Director, DMPK, Executive , New York, New York

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