Senior Manager, Clinical Pharmacology and Quantitative Pharmacology

Alexion Pharmaceuticals, Inc.; Mississauga; Hybrid; CAD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior Manager in Clinical Pharmacology and Quantitative Pharmacology to lead pharmacometric modeling efforts. This role involves developing and implementing modeling and simulation strategies to guide compounds from early trials to market. Collaborate with cross-functional teams to enhance pharmacometric capabilities and mentor junior scientists. Join a collaborative culture that values innovation and diversity, and make a meaningful impact in rare disease research. This is a fantastic opportunity for those ready to inspire and drive change in the pharmaceutical landscape.

Qualifications

• PhD or equivalent experience in quantitative sciences required.
• 2+ years in clinical pharmacology, PKPD, and QSP preferred.

Responsibilities

• Lead M&S strategies as a project leader in development teams.
• Conduct population PK and PKPD analyses for drug development.

Skills

R

SAS

NONMEM

Matlab

Mathematica

Quantitative System Pharmacology

Clinical Pharmacology

Data Analysis

Communication Skills

Education

PhD in Quantitative Sciences

Equivalent Experience

Tools

Matlab

SAS

NONMEM

Job description

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.

Introduction to role

Are you ready to lead the charge in pharmacometrics? As a Senior Manager in Clinical Pharmacology and Quantitative Pharmacology (CPQP), you will be at the forefront of PK-PD Modeling and Pharmacometrics (PMX). Your task involves developing and implementing Modeling & Simulation (M&S) plans and strategies, guiding compounds from early-stage trials to post-market phases. Collaborate with cross-functional teams within Alexion R&D, including Clinical Pharmacology, Translational Medicine, and Biostatistics, to enhance our PMX capabilities.

Your expertise will drive the continuous improvement of pharmacometrics skills, computational infrastructure, and strategic M&S methodologies across diverse projects and disease areas. Take charge of project-related M&S assignments, whether independently or in collaboration with external PMX CROs. Are you ready to make a difference?

Accountabilities

• Lead M&S strategies/plans as a project leader in cross-functional development teams.
• Apply brand new M&S methodologies to inform decision-making at crucial achievements.
• Build quantitative systems biology/pharmacology models with internal teams and external QSP service providers.
• Conduct population PK, PKPD analyses, clinical trial simulations, and model-based analyses.
• Initiate and coordinate outsourced M&S activities.
• Mentor and coach junior M&S scientists and CPQP scientists.
• Enhance Alexion's internal M&S capabilities through training and new tool evaluation.
• Prepare population PK/PD reports and regulatory submission documents.

Essential Skills/Experience

• PhD or equivalent experience in quantitative sciences
• 2+ years of pharmaceutical industrial and/or postdoctoral experience in the related teams 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

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

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.