Senior Manager, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

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. 

Senior manager CPQP position with focus on PK-PD Modeling and Pharmacometrics (PMX) is responsible for developing and executing Modeling & Simulation (M&S) plans and strategies and exposure response analyses for compounds from the early stage (first-in-human up to proof-of-concept) to the late-stage clinical development (proof-of-concept up to post market) in cross functional drug discovery and development project teams in close collaboration with colleagues in Clinical Pharmacology and Safety Sciences (CPSS), Translational Medicine, Clinical Development, Biostatistics, Research and other colleagues within Alexion R&D organization. This position will play a key role in strengthening the PMX and Modeling capability within Alexion by strongly contributing to the continuous improvement of pharmacometrics technical skillset, computational infrastructure and the strategic use of M&S methodologies across our projects and disease areas and optimizing the utilization of external PMX resources.

This position will also be responsible for his/her project related M&S assignments either executed independently or in collaboration with external PMX CROs. This position will:

1) Develop and execute population PK, PKPD, exposure response, dose selections for phase 3 strategies/plans and corresponding models for the pharmacometrics function from early clinical studies to Phase IV studies, and

2) Develop the quantitative system pharmacology strategies/plans and corresponding models for target identification, and compound design/characterization, translation from preclinical to FIH dose selection.

The incumbent will be responsible for the preparation of population PK/PD reports and corresponding regulatory submission documents. The incumbent will be expected to manage multiple development projects simultaneously and will participate in discussions and presentations to senior management.

Responsibilities:

• As M&S project lead in one or more cross functional development teams, will develop and execute M&S strategies/plans fully integrated with the overall preclinical and clinical development plans
• By using state-of-the-art M&S methodologies, will strongly contribute to decision making at critical milestones based on quantitative principles in close collaboration with CPSS, Biostats, Translational Medicine, Clinical Development, Research, and other quantitative disciplines
• Lead an internal matrix team(s) in building quantitative systems biology/pharmacology (QSP) models to support the activities from early discovery to FIH and beyond, in collaboration with leading external QSP service providers
• Perform population PK, PKPD-analyses, clinical trial simulations and other model-based analyses when appropriate
• Initiate and coordinate outsourced M&S activities on a regular basis
• Prepare population PK/PD reports and corresponding regulatory submission documents.

Essential Qualifications:

• A PhD, degree or equivalent in quantitative sciences
• 2+ years pharmaceutical industrial and/or postdoctoral experiences in the related disciplines of clinical pharmacology, PKPD, and QSP
• Excellent hands-on knowledge in R and/or SAS, NONMEM
• Excellent knowledge in Matlab, Mathematica, or other QSP related software or computing platform
• Under manager’s guidance, to become well-versed at analyzing, summarizing, plotting complex data to identify trends important for drug development
• Track record of applying quantitative system pharmacology methodologies in a drug R&D context
• Track record of publishing M&S work
• Experience from PMX approaches in hematology, nephrology, transplant, neurology, ophthalmology, and/or gene therapy rare diseases preferred
• Excellent written and verbal communication skills

Desirable:

• Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant discipline
• Background in clinical pharmacology or bioengineering is desired

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. 

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. 

#LI-Hybrid

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Annual base salary for this position ranges from 110,999.20 to 145,686.45.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.