Director of Clinical Pharmacology and Quantitative Pharmacology Clinical Res

Puesto: Director of Clinical Pharmacology and Quantitative Pharmacology  Clinical Res[...]
## Director of Clinical Pharmacology and Quantitative Pharmacology Barcelona, , Spain Apply Now Find out how well you match with this job
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* Job Title:

Director of Clinical Pharmacology and Quantitative Pharmacology
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* Location:

Barcelona
**** Hybrid working:
In the offcie 3 days per week
**** 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 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.
** 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…