Associate Director, Clinical Pharmacology - Hybrid (Boston)

Takeda Pharmaceutical Co.; Boston (MA); Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda is seeking an Associate Director, Clinical Pharmacology in the Cambridge, MA area. You will lead clinical pharmacology strategy, PK/PD modeling, and regulatory interactions to support PDT plasma-derived therapies.

The role requires a PhD/PharmD with 5+ years in pharma and hands-on modeling experience. Hybrid work is offered with collaboration across matrixed teams to advance regulatory filings and product development.

Qualifications

• PhD, PharmD or equivalent with 5+ years in clinical pharmacology within pharma.
• Hands-on pharmacometrics or modeling/simulation experience is required.
• Experience contributing to regulatory submissions and inquiries.

Responsibilities

• Represent Clinical Pharmacology on study teams and cross-functional groups.
• Plan and oversee clinical pharmacology aspects at the study/program level.
• Design and execute pharmacology and modeling plans for development/registration.
• Identify and manage pharmacometrics projects to support submissions.
• Contribute to regulatory documents and respond to queries from agencies.
• Oversee outsourcing activities with scientific and operational oversight.

Skills

Clinical pharmacology

Pharmacometrics

Modeling & simulation

Regulatory submissions

Cross-functional collaboration

Education

PhD/PharmD

Tools

Monolix

R

Job description

Takeda is seeking an Associate Director, Clinical Pharmacology in the Cambridge, MA area. You will lead clinical pharmacology strategy, PK/PD modeling, and regulatory interactions to support PDT plasma-derived therapies.

The role requires a PhD/PharmD with 5+ years in pharma and hands-on modeling experience. Hybrid work is offered with collaboration across matrixed teams to advance regulatory filings and product development.