The Director, CPQP position resideswithin Alexion’s Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead, the incumbentis expected to provide subject matter expertise and program level functional and operational leadership to the global development team(s) on all issues related to clinical pharmacology andquantitative pharmacology.

The Director will develop and manage assorted clinical pharmacology (CP) and quantitative pharmacology (QP) plansand assorted model-informed drug development strategies as appropriate (population analyses, exposure-response, PBPK, etc).The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posologyfor early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups. This role is a team-facing role requiring strong communication and inter-personal skills and will be responsible for leading a team of scientists to develop and manage the clinical pharmacology plans and exposure response analyses for compounds from the early stage (pre-clinical to first-in-human up to proof-of-concept) to the late-stage clinical development (proof-of-concept up to post marketing approval). 

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​​Principal Responsibilities​

Represent CPQP function at the Global Project Team and lead CPSS sub-team. 

Responsible for owning thedevelopment of the clinical pharmacology (PK, PD, biomarkers, Bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, and assorted QP analysis plans.

Contribute to the preparation of the pre-IND, IND, IB and IMPD documents.

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.

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 least10 years of pertinent 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 implementationin analyzing early- and late-stage clinical phase data, including applying modenformed drug development (MIDD) strategies to inform program decision-making.

​Knowledge of general regulatory process and experience in 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; including knowledge of the multidisciplinary functions involved in a company’s 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​

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.