Associate Director/Director, Pharmacometrics

Company: Agios Pharmaceuticals
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Associate Director/Director, Pharmacometrics Agios (agios.com) is a biopharmaceutical company focused on providing medicines for some of the world's most challenging diseases. We're committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform. We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities. We continue to foster a productive research engine that yields new insights and potential therapeutic approaches. We're a company that cares about our work, each other, and the people who are counting on us the most. We're inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results. We're driven to be our best selves, together, so we can reach for the Other Side of Possible. Agios Pharmaceuticals is searching for a dynamic Associate Director/Director to join our growing Pharmacometrics team. The Associate Director/Director will support the implementation of model-informed drug discovery and development (MID3) at Agios, including providing pharmacometrics strategy and quantitative rationale for dose and dosing regimen selection, safety margin, dose adjustment, patient selection/stratification, and pediatric investigation plans. The individual will act as a pharmacometrics lead to work independently with cross-functional teams, to provide pharmacometics deliverables related to internal decision-making or regulatory submissions. The individual should have strong knowledge of best regulatory practices, pharmacometric data structures, and analysis methodology. The individual is also expected to be an active scientific contributor through publications in the areas of quantitative clinical pharmacology and pharmacometrics. Key Responsibilities Represent pharmacometric group at cross-functional teams to provide modeling and simulation support to enable internal decisions and regulatory filings Be accountable for pharmacometrics deliverables, including preparing dataset specification and analysis plan, performing translational mechanism-based PK-PD modeling, population PK and exposure-response analyses, drug-disease modeling and clinical trial simulations, and writing up analysis report Manage outsourced pharmacometric work to ensure timely and high-quality deliverables Develop novel modeling and simulation methodology and establish new platforms to support the realization of MID3 Contribute to regulatory documents, and scientific publications in the areas of quantitative clinical pharmacology and pharmacometrics Minimum Requirements Ph.D. with at least 12 years of experience in pharmacometrics in pharmaceutical industry Strong understanding of model-based data analysis, simulation approaches, pharmacokinetics/pharmacology principles, and common statistical methodologies Extensive hands-on experience in population PK, PK/PD, exposure-response analyses, drug-disease modeling and clinical trial simulations Proficiency with use of WINNONLIN, NONMEM and R Experience in cross-functional interactions in matrix teams Preferred Qualifications Experience in rare disease drug development Experience with use of Monolix, Gastroplus and SAS

Keywords: Agios Pharmaceuticals, Cambridge , Associate Director/Director, Pharmacometrics, Other , Cambridge, Massachusetts