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Associate Director, Clinical Pharmacometrics

Alnylam Pharmaceuticals
United States, Massachusetts, Cambridge
675 West Kendall Street (Show on map)
Jan 30, 2025
Overview

The Associate Director, Quantitative Systems Pharmacology (QSP) will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. The candidate in this position should be well versed in systems pharmacology, clinical pharmacology, PK and PD with ability to critically evaluate and interpret data and conduct data analysis. In this role, the candidate is expected to show a high degree of scientific curiosity and critical thinking ability with good oral and written communication skills, ability to work independently with minimal supervision in a highly matrixed environment. The Associate Director, QSP will champion the application of QSP modeling and simulation approaches to answer key drug development questions across the portfolio spanning all stages of drug development.

Key Responsibilities

  • With minimal supervision, strategize, formulate and execute QSP modeling and simulation approaches for insights into dose selection, trial design, mechanistic understanding of the interaction between disease, biomarker and treatment response, predicting clinical outcomes etc.
  • Closely partner with clinical pharmacologist, pharmacometricians, research, clinical, non clinical modelers and other relevant R&D functions. Work closely with research and clinical functions to identify and interpret preclinical and clinical data to guide in data generation relevant for building and refining QSP models.
  • Build and utilize QSP models of biological or pathophysiological process to understand the disease pathways and effect of treatment intervention. Independently analyzes, interprets, and reports QSP modeling results for internal decision making.
  • Stay informed about advancement in QSP modeling methodologies. Be a technical leader within the group and mentor team members.
  • Establish and advance visibility and impact of QSP modeling internally and externally through publications in peer reviewed journals and presentations at scientific meetings.
  • Explore synergy between QSP and other modeling approaches to inform drug development decisions.

Qualifications

  • Candidates with a Ph.D (or equivalent) degree in applied mathematics, biomedical engineering, systems biology/pharmacology or related discipline.
  • At least 5 years of experience in pharmaceutical industry, consulting, or regulatory agency.
  • Track record of application of QSP modeling to impact drug development decisions.
  • Good understanding of systems biology, physiology, pharmacokinetics and pharmacodynamic principles. Strong foundation of theory, principles and statistical aspects of modeling and simulation including differential equation based modeling and parameter estimation/optimization approaches.
  • Extensive hands on experience with common QSP modeling platforms such as R, MATLAB, Simbiology etc.
  • Experience in translating and summarizing QSP modeling outcomes into information understood by project teams.
  • Open minded, receptive to input and a strong team player.
  • Self-driven, able to multi-task and manage time-sensitive deliverables.
  • Strong interpersonal skills with ability to collaborate and work in a matrix environment.
  • Strong written and oral presentation skills.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.

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