Hybrid Global Lead, Quantitative Clinical Pharmacology

Takeda Pharmaceutical Co.; Warszawa; Hybride; PLN 850 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Takeda, Warsaw, Poland, is seeking a Global Clinical Pharmacology and pharmacometrics Lead to manage multiple programs with high technical independence. You will collaborate with clinical sciences, biostatistics, programming, and regulatory affairs to drive study design, analysis, and regulatory submissions.

We value expert knowledge in PK/PD, late-state development, and lifecycle management, plus leadership in cross-functional teams.

Qualifications

• Pharm D. or PhD with 8+ years of experience in a quantitative field with some exposure to clinical pharmacology/PK-PD and pharmacometrics.
• Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
• Regulatory submissions experience (global submission experience preferred) and lifecycle management including pediatric development.
• Leadership in cross functional teams and proficiency in AI tools.

Responsabilités

• Provides scientific and strategic leadership as the Global Clinical Pharmacology and pharmacometrics Lead on Global Program Teams.
• Plans and executes clinical pharmacology studies in collaboration with partner functions.
• Represents Clinical Pharmacology in meetings with regulatory agencies and prepares regulatory summaries.
• Performs PK, PD, and pharmacometrics analyses and interprets PK/PD data.
• Maintains good clinical practice, compliance, and ethics.
• Mentors junior staff and leads cross-functional initiatives.

Connaissances

Pharmacometrician

PK/PD modeling

Clinical pharmacology

Regulatory submissions

R

SAS

NonMem

Python

Formation

Pharm D. or PhD in quantitative field

Other quantitative advanced degree (MS/PhD)

Outils

R

NonMem

SAS

Stan

Pheonix

Description du poste

Takeda, Warsaw, Poland, is seeking a Global Clinical Pharmacology and pharmacometrics Lead to manage multiple programs with high technical independence. You will collaborate with clinical sciences, biostatistics, programming, and regulatory affairs to drive study design, analysis, and regulatory submissions.

We value expert knowledge in PK/PD, late-state development, and lifecycle management, plus leadership in cross-functional teams.