Manager, Clinical Pharmacology/Quantitative Pharmacology

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 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.

The Manager, Clinical Pharmacology/Quantitative Pharmacology (CPQP), position is responsible for supporting data analyses, modeling & simulation (M&S), and document writing activities at all Phases of drug development. The focus is to propose and confirm the posology for Alexion’s developed medicines. The incumbent will coordinate multiple projects and be encouraged to complete activities independently or through management of external CROs. The position requires onsite participation on cross functional drug development teams, where discussions and presentations to program teams and governance bodies is expected. Finally, this role is key in strengthening the CPQP capability within Alexion by contributing to continuous improvement of pharmacometrics technical skills, computational infrastructure and the strategic use of M&S methodologies across our programs and disease areas.

Key Responsibilities:

• Leading CPQP-related projects on one or more cross functional development teams, developing and implementing M&S strategies/plans fully coordinated with overall preclinical and clinical plans. These projects will include (but are not limited to) NCA, population PK, PKPD analyses, clinical trial simulations, and other model-based analyses when appropriate.
• Introducing new M&S techniques to greatly enhance decision-making during key breakthroughs relying on quantitative principles in close collaboration with other quantitative subject areas.
• When needed, initiate and coordinate outsourced M&S activities.
• Preparing population PK/PD reports and corresponding regulatory submission documents.

Essential Education, Experience & Skills:

• A PhD, degree or equivalent in a quantitative science
• 1+ years pharmaceutical industry or equivalent experience in a related discipline such as clinical pharmacology, engineering, math/statistics, or computer science.
• Excellent hands-on knowledge in R, Julia, Python, NONMEM (or other NLME software).
• Excellent knowledge in Matlab or other QSP related software.
• Well versed at plotting complex data to identify trends important for drug development.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Experience & Skills:

• Experience in the application of mathematical modeling to hematology, nephrology, and/or neurological disorders and rare diseases.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.