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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 PK-PD Modeling and Pharmacometrics (PMX), guiding compounds from early-stage clinical development to post-market phases. Collaborate closely with cross-functional 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 cross-functional 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 data-driven 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, PKPD-analyses, clinical trial simulations, and other model-based 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 Alexion's 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 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, 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.
#LI-Hybrid
Date Posted
11-Apr-2025
Closing Date
29-Jun-2025
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 lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.