Senior Manager, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

Alexion Pharmaceuticals, Inc.; Mississauga; Hybrid; CAD 80,000 - 130,000; Full time

Job summary

Join a forward-thinking company at the forefront of rare disease research, where you will lead pharmacometrics and modeling efforts to drive life-changing medicines. In this dynamic role, you will collaborate with diverse teams to develop and implement innovative Modeling & Simulation strategies that guide compounds from early development to market. Your expertise in PK-PD modeling and quantitative systems pharmacology will be pivotal in influencing key decisions and improving our capabilities. If you are passionate about making a meaningful difference in patients' lives and thrive in a collaborative environment, this opportunity is perfect for you.

Qualifications

• PhD in quantitative sciences or equivalent with 2+ years in clinical pharmacology.
• Hands-on knowledge in R, SAS, and NONMEM essential for modeling.

Responsibilities

• Lead M&S project strategies in cross-functional teams.
• Develop population PK/PD reports and regulatory submissions.

Skills

Pharmacokinetics-Pharmacodynamics (PK-PD)

Modeling & Simulation (M&S)

R

SAS

NONMEM

Matlab

Mathematica

Quantitative Systems Pharmacology (QSP)

Clinical Pharmacology

Excellent communication skills

Education

PhD in quantitative sciences

Doctoral degree in clinical pharmacology or related field

Tools

R

SAS

NONMEM

Matlab

Mathematica

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 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

1. 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.
2. 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.
3. 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.
4. Perform population PK, PKPD-analyses, clinical trial simulations, and other model-based analyses when appropriate.
5. Initiate and coordinate outsourced M&S activities on a regular basis.
6. Mentor and coach junior M&S scientists and junior clinical CPQP scientists.
7. 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.
8. Prepare population PK/PD reports and corresponding regulatory submission documents.

Essential Skills/Experience

1. A PhD degree or equivalent in quantitative sciences.
2. Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacology/cell biology/immunology, or relevant field.
3. 2+ years of pharmaceutical industry or postdoctoral experience in the related fields of clinical pharmacology, PKPD, and QSP.
4. Excellent hands-on knowledge in R and/or SAS, NONMEM.
5. Excellent knowledge in Matlab, Mathematica, or other QSP related software or computing platform.
6. Under manager’s guidance, to become well versed at analyzing, summarizing, plotting complex data to identify trends important for drug development.
7. Track record of applying quantitative system pharmacology methodologies in a drug R&D context.
8. Track record of publishing M&S work.
9. Experience from PMX approaches in hematology, nephrology, neuromuscular, ophthalmology, bone, endocrinology, oncology, and/or metabolic rare diseases preferred.
10. Excellent written and verbal communication skills.

Desirable Skills/Experience

1. 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.