Associate Principal Scientist Pharmacology (Clinical) – Cell Therapy Full-time

Clinical Pharmacologist

The Clinical Pharmacologist is a scientific role that works with the project team to create clinical pharmacology development plans providing a clear strategy towards the right dose to patients. You will also design, conduct, analyze and interpret results from Clinical Pharmacology studies to support decisions at study and project level.

You will ensure state-of-the-art Clinical Pharmacology and Model-Informed Drug Development (MIDD) approaches are implemented to support AstraZeneca's cell therapy pipeline. Working closely with Pharmacometrician colleagues, you will oversee the development and delivery of analyzes that leverage foundational and cutting-edge pharmacometrics modeling techniques, in combination with business domain knowledge, to develop and apply advanced pharmacometrics modeling to clinical projects.

Responsibilities:

• Lead clinical pharmacology activities for assigned projects
• Use modeling and simulation to support decision making and dose selection
• Prepare relevant sections of clinical study protocols, reports, and regulatory documents
• Accountable for expert data integration, analysis, interpretation, and reporting of clinical pharmacology results at the study level to support project (project team/governance)
• Contribute to regulatory documents and interactions (written and oral)
• Present clinical pharmacology results to internal and external forums
• Contribute to internal projects to develop the clinical pharmacology discipline including its processes
• Compliance with Good Clinical Practice (GCP) regulations and internal/external guidance's

Education and Experience:

• PhD or equivalent in pharmacokinetics, pharmaceutical sciences, or a related discipline
• Experience of pharmacokinetics and Model-Informed Drug Development (MIDD)
• 3-6 Years of industry drug development experience in clinical pharmacology to support decision-making, dose selection, study design and regulatory interactions
• Hands on experience and advanced proficiency in using clinical pharmacology software including NONMEM, R, Phoenix WinNonlin
• Be able to work in a matrix team environment and influence the team with a data-driven approach
• Knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
• Relevant regulatory experience
• Prior cell therapy clinical pharmacology experience
• Experience in early and late-stage drug development

The annual base salary for this position ranges from $135,457.60 – $203,186.40. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).

Benefits offered include:

• A qualified retirement program [401(k) plan]
• Paid vacation, holidays, and paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.