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Associate Director, Pharmacometrics

Company: THIRD ROCK VENTURES, LLC
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Associate Director, Pharmacometrics at Magenta Therapeutics Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be applied through stem cell transplant to multiple diseases, including autoimmune diseases, such as multiple sclerosis and systemic sclerosis; blood cancers, such as acute myeloid leukemia; and genetic diseases, such as sickle cell disease. Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve. We are seeking an Associate Director, Pharmacometrics to conduct the design, analysis, interpretation, and reporting of quantitative analyses which integrate knowledge of pharmacokinetics, pharmacodynamics, patient/model characteristics, and/or disease states to optimize doses, dosage regimens and study designs. Support will focus on the entirety of Magenta's pipeline, including application of quantitative principles during early optimization of candidate selection through late-stage studies. As such, this position will be working closely with clinical pharmacologists, physicians, and other scientists, applying model informed drug development to contribute to the preclinical and clinical program, and influence key decisions in early and late development. This position offers a unique opportunity to work broadly across Magenta's pipeline, spanning all development stages and therapeutic indications. This individual will be a visible contributor to our teams, with responsibilities and input that are both scientific and operational in nature. Where appropriate, this position will be influential in directing Magenta's technical capabilities regarding the quantitative resources. - You are perfect for this role if you are engaged by and want to be responsible for:

  • Responsibilities cover project work from discovery, preclinical, and throughout clinical development (early and late stage).
  • Responsible for the planning and execution of relevant quantitative analyses which may include non-compartmental PK analysis, PK modeling focusing on application of Target Mediated Drug Disposition, population pharmacokinetics, PK/PD, exposure response, disease progression modeling, model-based meta-analysis, in collaboration with partners
  • Drive the pharmacometric contributions to protocol development, internal stage-gate reviews, regulatory/submission strategy, and related documents with oversight.
  • Identifies opportunities where modeling and simulation can advance the understanding of target engagement, PK-PD, efficacy, and safety.
  • May help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes
  • Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies and safety procedures. We would be thrilled if you brought the following with you:
    • PhD or equivalent (M.Sc./Pharm.D.) level expertise in a relevant field.
    • At least 3+ years of experience in pharmacokinetics, clinical pharmacology, and application of modeling & simulation in different phases of drug development
    • Experience in pharmacometric analyses and tools (e.g., Phoenix, NONMEM, R, GastroPlus)
    • Background in, and a clear understanding of clinical pharmacology aspects of drug development, preferably in both a small and large molecule settings
      Good knowledge of pharmacokinetics, PKPD and its clinical application
    • Biological understanding of disease and drug action, with focus on biologic therapeutics
    • Good oral and written communication skills Successful leaders and contributors within Magenta are: -
      • Driven. You will be focused on the achievement of Magenta's mission and major corporate goals.
      • Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way
      • Intuitive. -You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
      • Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
      • Process-oriented, yet flexible. -You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
      • Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders
      • Independent. -You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company
      • A role model for the company's cultural pillars; Courage, Commitment & Excellence At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together. 29 Newbury Street
        3rd Floor
        Boston, MA 02116
        P (617) 585-2000

Keywords: THIRD ROCK VENTURES, LLC, Cambridge , Associate Director, Pharmacometrics, Executive , Cambridge, Massachusetts

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