🚀 Director, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

Location: Barcelona Spain (3 days / week working from the office)

Overview

The Director CPQP position resides within Alexions Clinical Pharmacology and Safety Sciences (CPSS) organization . As the CPQP lead the incumbent is expected to provide subject matter expertise and program level functional leadership on issues related to clinical pharmacology pharmacokinetics and pharmacodynamics (PK / PD) rare oncology and genetic medicines from the pre-clinical stage up to the registration stage ). The role represents the CPQP function on drug development teams lead CPQP sub-teams and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians clinical operations bioanalytical biomarker pharmacovigilance regulatory and CMC groups .

Responsibilities

• Represent CPQP function at the Global Project Team and lead CPQP sub-team.
• Responsible for providing support for the preparation of the clinical pharmacology (PK PD biomarkers Bioanalytical) sections of early and late-stage clinical protocols Clin Pharm development plans M&S plans.
• Contribute to the preparation of the pre-IND IND IB and IMPD documents.
• Responsible for the pharmacokinetic and PK / PD data analyses using standard industry data analysis software.
• Contribute to the design of early phase clinical trials (FIH to POC) and support project goals.
• Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based modeling or QSP modeling; Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC; Contribute to the design of late-stage clinical trials (POC-BLA / NDA) and support project goals.
• Responsible for the preparation of the PK / PD reports / sections of clinical study reports.
• Provide clinical pharmacology input and collaborate across all areas of drug development. Special emphasis on providing clinical pharmacology aspects of genetic medicines to research toxicology immunogenicity clinical and commercial team colleagues.
• Primary owner of delivering pharmacokinetic / pharmacodynamic data analyses using standard industry data analysis software.
• Responsible for delivering clinical pharmacology components of clinical study protocols and clinical study reports.

Qualifications

• Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology pharmacology / cell biology / immunology or relevant discipline.
• At least 10 years of pertinent post-doctoral experience in supporting pharmacokinetics pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry.
• Exposure to genetic medicine and biologics drug development. Knowledge of clinical immunology and virology is a plus.
• Knowledge of data analysis methodologies for implementation in analyzing early clinical phase data.
• Knowledge of general regulatory process and experience in contributing to IND EOP1 EOP2 and pre-BLA / NDA meetings with the FDA and EMA.
• Experience in rare diseases oncology genomic medicine and / or cell therapy clinical development.
• Excellent written and oral communication skills including good presentation skills.
• Strong business acumen; including knowledge of the multidisciplinary functions involved in a companys drug development process e.g. clinical operations research biostatistics clinical pharmacology regulatory commercial operations etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results.

Education

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

Date Posted: 08-oct-2025

Closing Date: 27-oct-2025

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