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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.
The impact you will make:
Agios Pharmaceuticals is searching for a dynamic 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 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.
What you will do:

• 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

What you bring:

• Ph.D. with at least 5 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. You may be just the right candidate for this role or another opening!
Work Location:
Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
  • The current base salary range for this position is expected to be between $149,069 and $223,604 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.