Director, Clinical Pharmacology and Quantitative Pharmacology

Location: Barcelona Spain (3 days/week working from the office) 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, leads 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. Principal Responsibilities 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, clinical pharmacology development plans, and M&S plans. Contribute to the preparation of the pre‑IND, IND, IB and IMPD documents. Perform 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. Recommend the starting dose in FIH trials based on allometric scaling, 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 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. Deliver 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; knowledge of the multidisciplinary functions involved in a company’s drug development process (e.g., clinical operations, research, biostatistics, clinical pharmacology, regulatory, commercial operations) and ability to 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. Alexion is proud to be an Equal Employment Opportunity and affirmative action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy (including childbirth, breastfeeding or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E‑Verify. #J-18808-Ljbffr