Director, Clinical Pharmacology and Quantitative Pharmacology (CPQP)

The Director, CPQP position resides within Alexion’s Clinical Pharmacology and Safety Sciences (CPSS) organization. As the CPQP lead, you will provide subject matter expertise and program-level functional leadership on issues related to clinical pharmacology, pharmacokinetics, and pharmacodynamics (PK/PD), cell therapies, and genetic medicines from the pre-clinical stage up to the registration stage. You will represent the CPQP function on drug development teams, lead CPQP sub-teams, and own 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.

Accountabilities

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

- Provide 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.

- Conduct pharmacokinetic and PK/PD data analyses using standard industry data analysis software.

- Design early phase clinical trials (FIH to POC) and support project goals.

- Recommend starting doses in FIH trials based on allometric scaling or physiologically based modeling or QSP modeling; assess relevant exposure vs. response data for supporting dose selection during and post POC; design late-stage clinical trials (POC-BLA/NDA) and support project goals.

- Prepare PK/PD reports/sections of clinical study reports.

- Provide clinical pharmacology input and collaborate across all areas of drug development with a special emphasis on genetic medicines.

- 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 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.

- 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 genomic medicine and/or cell therapy clinical development. Hands-on exposure to development issues related to recombinant DNA biology, bacterial production of plasmids, cell line biology, viral production, molecular analytical assays (qPCR, ddPCR, etc.), biochemistry analytical assays (ELISA, enzymatic activity, etc.), biophysics analytical assays (HPLC, DLS, CE-SDS, etc.), microscopy, tissue imaging (IHC, fluorescence microscopy), flow cytometry.

- Excellent written and oral communication skills including good presentation skills.

- 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.

Desirable Skills/Experience

- Exposure to genetic medicine and biologics drug development. Knowledge of clinical immunology and virology is a plus.

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 we need 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.

At AstraZeneca's Alexion division, you will find an environment where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape with a rapidly expanding portfolio. Our closeness to patients brings us closer to our work and each other. With a pioneering spirit and a commitment to innovation, we offer a unique blend of entrepreneurial spirit with the security of a global pharma. Here you can grow your career while making a real impact on patients' lives.

Ready to make a difference? Apply now!

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.