Director, Clinical Pharmacology & Pharmacometrics at AstraZeneca

Gaithersburg, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

16 May, 26

Salary

254000.0

Posted On

15 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Pharmacology, Pharmacometrics, Cell Therapy, Quantitative Strategy, Model-Informed Drug Development (MIDD), Exposure-Response Modeling, Dose Optimization, Mechanistic Models, Empirical Models, Trial Design, Dose Selection, Regulatory Interactions, NONMEM, Phoenix/NLME, R, SAS

Industry

Pharmaceutical Manufacturing

Description

The Director, Clinical Pharmacology & Pharmacometrics will set and execute the quantitative strategy across a diverse portfolio of cell therapy products, translating advanced cellular kinetics and exposure–response modeling into dose optimization, patient selection, program decision and strategy. You will ensure state of the art model-informed drug development (MIDD) is implemented to support AstraZeneca's cell therapy pipeline, integrating cutting edge modeling with novel cell therapy biomarkers, translational endpoints, and clinical data. Working cross functionally and with external partners, you will build mechanistic and empirical models, advise trial design and dose selection, and grow capabilities through mentoring and knowledge sharing. You may be based in Gaithersburg, MD or Santa Monica, CA and will report to Senior Director, Clinical Pharmacology. Responsibilities: Build MIDD across cell therapy portfolio. Lead quantitative strategies across all phases, including CK characterization, exposure–response for efficacy and safety. Develop mechanistic and empirical models, enabling clear decision making, optimized dosing regimen, and streamlined development paths. Partner with project team (clinical, translational medicine, CMC, etc.) to link patient characteristics and product attributes to clinical outcomes. Ensure modeling strategies align with regulatory expectations (e.g., FDA MIDD), supporting submissions, dose justifications, and scientific advice. Provide peer review and mentoring across programs to strengthen scientific rigor and consistency in pharmacometrics practice. Monitor and adopt emerging methodologies (QSP for cell therapies, AI/ML for biomarker integration, MIDD regulatory pilots, etc.). Advance AstraZeneca’s leadership through speaking, publications, and consortium participation in cell therapy modeling. Education and Experience: PhD in pharmacometrics, pharmacokinetics, biostatistics, or related discipline. At least 6 Years of industry drug development experience in pharmacometrics supporting decision-making, dose selection, study design and regulatory interactions. Hands on experience and advanced proficiency in using pharmacometrics software including NONMEM, Phoenix/NLME, R, SAS, Python, etc. 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 pharmacometrics. Ability to plan and implement pharmacometrics approaches (PopPK, PKPD, exposure–response, QSP, Bayesian/adaptive methods) that drive dose selection and enable go/no-go decisions. Integration of quantitative pharmacology with innovative biomarkers, AI enabled analyses, novel endpoints, and adaptive trial design. Experience in application of AI and ML in pharmacometrics highly desirable. Pharmacometrics experience across cell therapy platforms (CAR T, TCR, autologous, allogeneic, in vivo, etc.) and disease areas (hematology, oncology, immunology, etc.) desirable. #CellTherapy The annual base pay for this position ranges from $169K to $254K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. Date Posted 14-Feb-2026 Closing Date 01-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Director will set and execute the quantitative strategy for cell therapy products, translating advanced cellular kinetics into dose optimization and decision-making across the pipeline. This involves building mechanistic and empirical models, advising on trial design, and ensuring state-of-the-art Model-Informed Drug Development (MIDD) is implemented.