Director, Clinical Pharmacology and Quantitative Pharmacology

Introduction to role

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 and operational leadership to the global development team(s) on all issues related to clinical pharmacology and quantitative pharmacology. You will develop and manage assorted clinical pharmacology (CP) and quantitative pharmacology (QP) plans and model-informed drug development strategies as appropriate (population analyses, exposure-response, PBPK, etc). Representing the CPQP function on drug development teams, leading CPQP sub-teams, and owning strategy and delivery on posology for early and late-stage clinical trials, you will collaborate with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory, and CMC groups. This 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 clinical development (proof-of-concept up to post-marketing approval).

Accountabilities

• 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, Clin Pharm development plans, and assorted QP analysis plans.
• Prepare the pre-IND, IND, IB, and IMPD documents.
• Design early phase clinical trials (FIH to POC) and support project goals.
• Recommend 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.
• Prepare 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.
• 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 field.
• At least 10 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 implementation in analyzing early- and late-stage clinical phase data, including applying model-informed 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.
• Strong discernment; 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 the best end-results!

Desirable Skills/Experience

• Prior multi-disciplinary team-facing experience in a CPQP role is preferred.

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 Alexion, AstraZeneca Rare Disease, we are driven by our commitment to serve patients. Our work is led by their lived experiences, driving what we do and how we do it. We know our patients by name; we meet their families and their careers. Our close connection with patients inspires us to tackle the toughest challenges for them. Join us to grow and innovate in a rapidly expanding portfolio within a supportive culture that values integrity, inclusiveness, and dedication.

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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.