Hybrid Associate Director, Clinical Pharmacology

Takeda; Boston (MA); Hybride; USD 154 000 - 243 000; Plein temps

Résumé du poste

Takeda in Cambridge, MA is seeking an Associate Director, Clinical Pharmacology to lead pharmacology strategies across PDT R&D projects. This role requires strategic thinking, strong communication, and deep expertise in clinical pharmacology and pharmacometrics.

You will represent Clinical Pharmacology on cross-functional teams, design pharmacology and modeling plans for development and regulatory submissions, and oversee outsourcing activities. Boston location noted with hybrid work model.

Qualifications

• Ph.D., PharmD or equivalent with 5+ years of clinical pharmacology in pharma.
• Hands-on pharmacometrics or modeling and simulation experience.

Responsabilités

• Represent Clinical Pharmacology on study/program teams and multi-functional groups.
• Plan and oversee clinical pharmacology aspects at study/program level (dose justification, PK/biomarker measurement strategies, protocol authoring, analysis planning).
• Design and execute clinical pharmacology plans and modeling plans to support development, registration and commercialization of Takeda’s plasma-derived products.
• Identify and oversee pharmacometrics projects for program development and regulatory submissions; integrate PK/PD and patient characteristics to optimize dose and study design.
• Contribute to regulatory documents and responses; lead resolution of pharmacology queries from agencies.
• Manage outsourcing activities (contract requisition, SOWs, invoices) with oversight.

Connaissances

Clinical pharmacology

Pharmacometrics

Modeling & simulation

Regulatory submissions

Cross-functional leadership

Formation

Ph.D./PharmD or equivalent

Outils

Monolix

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Description du poste

Takeda in Cambridge, MA is seeking an Associate Director, Clinical Pharmacology to lead pharmacology strategies across PDT R&D projects. This role requires strategic thinking, strong communication, and deep expertise in clinical pharmacology and pharmacometrics.

You will represent Clinical Pharmacology on cross-functional teams, design pharmacology and modeling plans for development and regulatory submissions, and oversee outsourcing activities. Boston location noted with hybrid work model.