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Skilled - Recruitment Solutions GmbH , Region Baden-Württemberg
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Skilled - Recruitment Solutions GmbH , Region Wallis
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Associate Director / Director Pharmacometrics
Position
Associate Director / Director PharmacometricsRegion
Basel-StadtPositionsnummer
PA208217042024Aufgaben
Job Summary: We are seeking a talented individual with expertise in Clinical Pharmacology and Pharmacometrics to join our dynamic team. In this role, you will utilize your knowledge to analyze pharmacokinetics/pharmacodynamics and drive model-informed drug development across various drug development programs. Collaborating with a diverse range of stakeholders, you will develop compound-specific Pharmacometrics strategies and lead regulatory efforts in Clinical Pharmacology. Additionally, you will play a pivotal role in supporting early portfolio development, facilitating seamless transitions to late-stage development and regulatory submission.
Key Responsibilities:
*Apply expertise in PK, PK/PD, and model-informed drug development principles
*Serve as the modeling and simulation representative on project teams
*Collaborate with clinical, pre-clinical, biostatistics, and regulatory teams, as well as external partners
*Conduct population PK/PD and exposure-response modeling to inform dose selection and trial design
*Prepare pharmacometrics reports, manuscripts, and regulatory submissions
*Enhance the efficiency of modeling and simulation capabilities through training and adoption of new methodologies
*Manage CROs for pharmacometric studies, from planning to final report
*Recommend doses for early-phase studies and contribute to asset development strategies
*Support the preparation of regulatory documents and responses to reviewer queries
*Participate in strategic initiatives and represent the Clinical Pharmacology function at project review meetings
Qualifikationen
- PhD or equivalent degree in Pharmaceutical Sciences, Pharmacometrics, Clinical Pharmacology, Mathematics, Statistics, or related field
- 8-10 years of industry experience
- Experience with FDA and EMA submissions
- Proficiency in Pop-PK, PKPD modeling, PBPK modeling, and clinical trial simulations
- Strong skills in modeling tools such as NLME, NONMEM, R, or Phoenix WinNonlin
- Knowledge of health authority perspectives on modeling and simulation
- Experience with pharmacometrics analysis for regulatory submissions preferred
- Ability to adapt to changing priorities and timelines efficiently