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 lifechanging medicines. Inperson working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Introduction to role

Are you ready to lead the way in pharmacometrics and modeling Lead the development and implementation of Modeling & Simulation (M&S) plans at Alexion. Your focus will be on PKPD Modeling and Pharmacometrics (PMX) guiding compounds from earlystage clinical development to postmarket phases. Collaborate closely with crossfunctional teams including Clinical Pharmacology and Safety Sciences (CPSS) Translational Medicine Clinical Development Biostatistics and Research. Your expertise will strengthen our PMX and Modeling capabilities ensuring continuous improvement in pharmacometrics technical skills computational infrastructure and strategic use of M&S methodologies.

Accountabilities

As M&S project lead in one or more crossfunctional development teams develop and implement M&S strategies/plans fully coordinated with the overall preclinical and clinical plans

Apply new M&S methods to influence key decisions using datadriven principles collaborating closely with CPSS Biostats Translational Medicine Clinical Development Research and other quantitative fields.

Lead an internal matrix team(s) in building quantitative systems biology/pharmacology (QSP) models to support activities from early discovery to FIH and beyond in collaboration with leading external QSP service providers

Perform population PK PKPDanalyses clinical trial simulations and other modelbased analyses when appropriate

Initiate and coordinate outsourced M&S activities on a regular basis

Mentor and coach junior M&S scientists and junior clinical CPQP scientists

Strengthen and build Alexions internal M&S capability on a continuous basis by initiating training activities evaluating and introducing new M&S tools and computing platforms as appropriate

Prepare population PK/PD reports and corresponding regulatory submission documents

Essential Skills/Experience

A PhD degree or equivalent in quantitative sciences

Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology pharmacology/cell biology/immunology or relevant field

2 years of pharmaceutical industry or postdoctoral experience in the related fields of clinical pharmacology PKPD and QSP

Excellent handson knowledge in R and/or SAS NONMEM

Excellent knowledge in Matlab Mathematica or other QSP related software or computing platform

Under managers 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 neuromuscular ophthalmology bone endocrinology oncology and/or metabolic rare diseases preferred

Excellent written and verbal communication skills

Desirable Skills/Experience

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.

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Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.