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DMPK Project Leader
Sin especificarTiempo completoDrug Product DevelopmentPharmaceuticalsBiotechnology
Lead DMPK strategy and execution across drug discovery and development programs involving small molecules and biologics. Partner with cross-functional teams to guide study design, interpret data, and inform development decisions.
Responsabilidades
- Design, oversee, and interpret in vitro and in vivo ADME/PK studies for small molecules and biologics
- Analyze PK/toxicology and ADME data, including human PK predictions and clinical translation
- Manage CRO relationships and ensure study quality, regulatory compliance, and alignment with IND-enabling requirements
- Author and review DMPK sections of regulatory documents and respond to agency queries
- Advise discovery, toxicology, pharmacology, and early clinical teams on PK/toxicology strategies and data interpretation
- Integrate new technologies and methods into PK and toxicology assessments
Requisitos
- PhD in Pharmaceutical Sciences, Medicinal Chemistry, or a related field
- At least 4 years of industry experience in DMPK
- Experience in small-molecule and biologic drug development
- Knowledge of monoclonal and bispecific antibody pharmacokinetics, including FcRn interactions, target-mediated drug disposition, and immunogenicity
- Experience with regulatory submissions and GLP-compliant studies
- Strong communication skills and ability to present complex data to varied audiences
Se valora
- Expertise in drug metabolism and drug-drug interaction potential
- Familiarity with bioanalytical assay development for small and large molecules
- Experience with first-in-human studies and clinical pharmacology planning
- Experience supporting marketed products and lifecycle management
Beneficios
- Generous annual leave
- Reward plans
- Flexible working schedules, depending on the role
- Tailored health support
- Career development and internal growth opportunities