Director, Clinical Pharmacology and Quantitative Pharmacology

Alexion Pharmaceuticals Company; Mississauga; On-site; CAD 130,000 - 170,000; Full time

Job summary

A leading pharmaceutical company in Mississauga is seeking a Director CPQP to provide leadership in clinical pharmacology. The role involves developing and managing clinical pharmacology plans and leading a team of scientists. Candidates should have a doctoral degree and substantial experience in pharmacokinetics and pharmacodynamics. This position offers a full-time role within a dynamic team committed to making a positive impact on patients' lives.

Qualifications

• At least 10 years of post-doctoral experience in related fields.
• Experience in supporting pharmacokinetics and pharmacodynamics for clinical trials.
• Knowledge of model-informed drug development strategies.

Responsibilities

• Lead CPQP function at the Global Project Team.
• Develop clinical pharmacology development plans and analysis plans.
• Collaborate across all areas of drug development.
• Design early and late-stage clinical trials.

Skills

Strong communication skills

Interpersonal skills

Knowledge of regulatory processes

Data analysis methodologies

Education

Doctoral degree (PhD or equivalent) in related field

Job description

Overview

The Director CPQP position resides within AstraZeneca's Alexion division, within the Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead you will provide subject matter expertise and program-level functional and operational leadership to global development teams on CPQP-related issues. You will develop and manage clinical pharmacology (CP) and quantitative pharmacology (QP) plans and model-informed drug development strategies (e.g., population analyses, exposure–response, PBPK). Representing CPQP on drug development teams, you will lead CPQP sub-teams and own strategy and delivery on posology for early and late-stage clinical trials, collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory, and CMC groups. The role requires strong communication and interpersonal skills and involves leading a team of scientists to develop and manage clinical pharmacology plans and exposure–response analyses for compounds from early-stage (pre-clinical to first-in-human up to proof-of-concept) to late-stage development (POC to post-marketing approval).

Responsibilities

• Represent CPQP function at the Global Project Team and lead CPSS sub-team.
• Lead the development of the clinical pharmacology (PK/PD, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, clinical pharmacology development plans, and assorted QP analysis plans.
• Contribute to the preparation of pre-IND, IND, IB, and IMPD documents.
• Design early phase clinical trials (FIH to POC) and support project goals.
• Set starting dose in trials using scaling or modeling; evaluate exposure vs. response data for dosing decisions.
• Design late-stage clinical trials (POC-BLA/NDA) and support project goals.
• Prepare PK/PD reports and sections of clinical study reports.
• Provide clinical pharmacology input and collaborate across all areas of drug development.
• Deliver pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software.
• Deliver clinical pharmacology components of clinical study protocols and clinical study reports.

Essential Skills / Experience

• Doctoral degree (PhD or equivalent) in clinical pharmacology, pharmacology, cell biology, immunology, or a relevant field.
• At least 10 years of post-doctoral experience in supporting pharmacokinetics, pharmacodynamics, and other CP and QP components of early- and late-stage clinical trials.
• Knowledge of data analysis methodologies for early- and late-stage clinical data and model-informed drug development (MIDD) strategies to advise program decisions.
• Knowledge of regulatory processes and experience contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA and EMA.
• Excellent written and oral communication skills, including good presentation skills. Prior multi-disciplinary team-facing experience in a CPQP role is preferred.
• Strong business acumen and ability to integrate multiple perspectives from clinical operations, biostatistics, regulatory, and other functions into the development process.

Desirable Skills / Experience

• Experience with Genetic Medicine development is preferred.

About the Organization

When we put unexpected teams in the same room, we ignite bold thinking and connect work at pace. We balance in-office expectation with individual flexibility. We are part of AstraZeneca’s Alexion division, a patient-driven culture that values diversity and inclusion and seeks to make a real difference in patients’ lives. We offer tailored development programs and a supportive community of leaders and peers.

Application Details

Ready to make an impact? Apply now to join our team!

Date Posted: 12-Sep-2025

Closing Date: 17-Sep-2025

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. We comply with applicable non-discrimination laws, work authorization, and employment eligibility requirements.

Job Information

• Employment Type : Full-Time
• Experience : years
• Vacancy : 1