Director of Clinical Pharmacology and Quantitative Pharmacology

1. Job Title: Director of Clinical Pharmacology and Quantitative Pharmacology 2. Introduction to role: Are you ready to lead model-informed drug development that shapes dose strategy from first-in-human through registration? In this Barcelona-based leadership role, you will guide the clinical pharmacology and quantitative pharmacology vision across programs, turning data into decisive actions that accelerate breakthrough medicines to patients. You will partner closely with clinicians, clinical operations, bioanalytical and biomarker experts, pharmacovigilance, regulatory and CMC colleagues to deliver clear, evidence-based posology and trial designs. How will you use population analyses, exposure-response and PBPK to influence pivotal decisions and raise the probability of technical and regulatory success? 3. Accountabilities: - Program Leadership: Represent CPQP on the Global Project Team and lead the function’s sub-team, owning the strategy and delivery of clinical pharmacology and posology across early and late development. - Model-Informed Drug Development: Develop and execute CP/QP plans and analysis strategies (population PK/PD, exposure-response, PBPK, QSP) to inform dose selection, benefit-risk assessment and scenario planning; act as the primary owner of PK/PD analyses using industry-standard software. - Clinical Strategy and Trial Design: Lead the CP sections of early and late-stage protocols and development plans; recommend first-in-human starting dose via allometric scaling or physiologically based modeling or QSP; drive dose optimization during and after proof-of-concept; shape late-stage trial designs to meet program goals. - Regulatory Influence and Documentation: Contribute to pre-IND, IND, IB and IMPD packages; prepare PK/PD sections and the clinical pharmacology components of clinical study protocols and clinical study reports; articulate MIDD rationale and outcomes to internal governance and health authorities. - Cross-Functional Partnership: Provide integrated clinical pharmacology input across research, toxicology, immunogenicity, clinical and commercial stakeholders, with special emphasis on genetic medicines and associated bioanalytical and biomarker strategies. - People Leadership: Lead and develop a team of scientists; set high standards for scientific rigor, clear communication and timely delivery; cultivate capabilities that embed MIDD thinking across programs. 4. 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 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. 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 5. Desirable Skills/Experience: - Proven leadership of clinical pharmacology and quantitative pharmacology scientists and external partners across multiple programs. - Hands-on proficiency with population PK/PD, exposure-response, PBPK and QSP toolsets (e.g., NONMEM, Monolix, Phoenix, Simcyp). - Experience shaping posology strategies in complex or rare disease areas, including immunology or complement-mediated conditions. - Track record of authoring IB, IMPD and clinical pharmacology summaries that influence regulatory strategy and decisions. - Publications or conference presentations showcasing innovative CP/QP or MIDD approaches. - Experience integrating clinical pharmacology considerations for genetic medicines, including immunogenicity and bioanalytical/biomarker strategies. 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. 6. Why AstraZeneca: Here, science leads and you have the platform to make it count. We bring together unconventional combinations of experts to probe the biology of complex disease, fuse data science and advanced modeling with deep clinical insight, and design smarter studies that better predict clinical success. You will be part of a collaborative, kind and ambitious community that learns fast, shares openly and turns tough uncertainties into bold, evidence-based decisions for patients worldwide. 7. Call to Action: Step into this Barcelona-based leadership role and shape dose strategy for transformative medicines—advance your impact and share your CV to start the conversation!

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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.