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!

The annual base pay (or hourly rate of compensation) for this position ranges from $ 135,458 to $203,186. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. 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 included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, 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. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

19-Feb-2025

Closing Date

18-Mar-2025Our 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.