30 jul
|
Astrazeneca
|
España
30 jul
Astrazeneca
España
Job Title
Director of Clinical Pharmacology and Quantitative Pharmacology
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?
Accountabilities
- Program Leadership: Represent CPQP on the Integral 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 integrate
📌 Director of Clinical Pharmacology and Quantitative Pharmacology (España)
🏢 Astrazeneca
📍 España