Sr. Scientist​/Associate Director, Pharmacometrics

Sr. Scientist/Associate Director, Pharmacometrics

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives.

In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

Agios Pharmaceuticals is searching for a dynamic Sr. Scientist or Associate Director to join our growing Pharmacometrics team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Sr. Manager or Associate Director, Pharmacometrics will be responsible for implementation of model‑informed drug discovery and development at Agios, including providing pharmacometrics strategy and quantitative rationale for dose regimen selection, safety margins, patient selection/stratification, and pediatric investigation plans.

The Associate Director will act as a pharmacometrics lead and work independently with cross‑functional teams, to deliver pharmacometrics analysis supporting internal decision‑making or regulatory submissions. The Associate Director is also expected to be an active scientific contributor through publications in the areas of quantitative clinical pharmacology and pharmacometrics.

• Represent the pharmacometrics group at cross‑functional teams to provide modeling and simulation support and enable internal decisions
• Develop pharmacometrics analysis plans, prepare dataset specifications, perform translational mechanism‑based PK‑PD modeling, population PK and exposure‑response analyses, drug‑disease modeling and clinical trial simulations, and prepare analysis reports
• Manage outsourced pharmacometrics work to ensure timely and high‑quality deliverables
• Plan and execute pharmacometrics contributions to regulatory filing strategy and related documents (e.g. briefing books, summaries of clinical pharmacology/efficacy/safety, responses to regulatory authority questions)
• Participate in evaluation of novel modeling and simulation methodology and new platforms
• Contribute to scientific publications in the areas of quantitative clinical pharmacology and pharmacometrics

• Ph.D. with at least 4 years of experience in pharmacometrics in pharmaceutical industry or a Master’s Degree or equivalent education and 10+ years of experience in pharmacometrics in pharmaceutical industry
• Strong understanding of model‑based data analysis, simulation approaches, pharmacokinetics/pharmacology concepts, and common statistical methodologies
• Extensive hands‑on experience in small molecule and protein population PK/PD modeling, exposure‑response analyses, drug‑disease modeling and clinical trial simulations
• Proficiency with use of WINNONLIN, NONMEM, and R
• Experience with use of Simcyp, Monolix, Gastroplus, and SAS
• Experience in cross‑functional interactions in matrix teams
• Experience in rare disease drug development

Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply.…