Director of Clinical Pharmacology and Quantitative Pharmacology

Job Title: Director of Clinical Pharmacology and Quantitative Pharmacology

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 functions 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 companys 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

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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.

Step into this Barcelona-based leadership role and shape dose strategy for transformative medicinesadvance your impact and share your CV to start the conversation!

Date Posted

Closing Date

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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.