Associate Director (Clinical Pharmacometrics)

Associate Director (Clinical Pharmacometrics)

Location: Gaithersburg, MD

Introduction to role

This is a scientific role with responsibility for pharmacometrics (PMx) activities in the Vaccine and Immune (V&I) Therapy Area, including population PK, PKPD, exposure-response, disease modelling, and simulations in all clinical development phases. With support from the V&I Group Director and the V&I Therapy Area Head, you will integrate and analyze internal and external data to support interpretation and decision-making at both study and project levels.

You will drive the application of foundational and cutting-edge pharmacometrics techniques, combined with business domain knowledge, to develop and apply advanced modelling to generate business and scientific insights. You will coordinate the creation, maintenance, and improvement of advanced pharmacometric models for ongoing and ad hoc review and analysis. Additionally, you will provide coaching, task management, and support to junior staff while promoting best practices across multiple domains and stakeholder groups.

Accountabilities

• Develop modeling & simulation (M&S) strategy to support dose selection at all stages

• Analyze M&S data, interpret results, and convey clear messages to project teams

• Deliver key messages to LM, TA heads, and function heads alongside CPL

• Contribute to key regulatory meetings, such as EOP2

• Inform LM, TA head, and function head with key messages

• Use M&S to influence study designs and go/no-go decisions

• Contribute to regulatory documents and interactions (oral/written)

• Support evaluation of candidates for in-licensing

• Contribute to internal initiatives to develop the pharmacometric discipline including its processes

• Supervise modelling work performed by external contractors

• Ensure compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance

• Represent AZ by publishing research findings, speaking at conferences, and organizing symposia

Essential Skills/Experience

• PhD degree or equivalent (Pharm.D.) with 5+ years of pharmacometrics experience

• Demonstrated expertise in pharmacometrics, including PK, PKPD and/or statistics

• Strong quantitative skills (e.g. experience in population modelling, statistics, systems and translational pharmacology modelling)

• Expert knowledge of pharmacokinetics and Model-Informed Drug Development (MIDD)

• Demonstrated broad translational and clinical development expertise and experience exemplified by 5+ years of drug development experience, with emphasis on Clinical Pharmacometrics 

• Demonstrated ability to identify, develop and execute Pharmacometrics activities at a project level

• Excellent oral and written communication skills

• Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology

• Relevant regulatory experience (written)

• Training and experience with PK and statistical software (NonMem, R, Stan, Winbugs ,SAS, Monolix , Phoenix, WinNonlin)

Desirable Skills/Experience

• Prior industry experience is preferred

• Scientific publishing in the field on pharmacometrics 

• Early or late phase clinical development experience/awareness 

• Knowledge in pharmacology, drug targets and core disease areas 

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, you will play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables and embrace global opportunities across all of AstraZeneca's Therapy Areas. We are always moving forward with a restless need to keep improving. Our supportive yet challenging approach creates an inspiring learning environment where every setback is seen as a chance to improve. We combine specialist knowledge with curiosity, always searching for better ways of doing things to achieve the best results.

Ready to make a difference? Apply today!

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