Global Director, Clinical Pharmacology & PK/PD Strategy

Takeda; Cambridge (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda is seeking a Director of Clinical Pharmacology for its Cambridge, MA office. The role leads clinical pharmacology programs across plasma-derived products, ensures regulatory strategy alignment, and drives pharmacometrics activities within a matrixed R&D environment.

The successful candidate will guide project progression from entry to development and lifecycle management, interacting with global teams and regulatory bodies. Strong communication and strategic thinking are essential.

Qualifications

• PhD/PharmD/MD with at least 10 years in clinical pharmacology in pharma.
• Educational background in clinical pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or related field.

Responsibilities

• Design clinical pharmacology programs for development, registration and commercialization.
• Represent Clinical Pharmacology on product development teams and provide input across drug development.
• Lead design, execution and reporting of clinical pharmacology studies.
• Oversee pharmacometrics projects to support progression and regulatory submissions.
• Contribute to regulatory documents and respond to regulatory questions.
• Write/review Clinical Pharmacology Plans and Reports.
• Manage outsourcing activities and budgets.

Skills

Clinical pharmacology

PK/PD

Regulatory submissions

Matrix leadership

Communication skills

Team collaboration

Education

PhD/PharmD/MD or equivalent

Clinical pharmacology/biopharmaceutics background

Tools

NonMEM

Phoenix NLME

Regulatory documentation tools

Job description

Takeda is seeking a Director of Clinical Pharmacology for its Cambridge, MA office. The role leads clinical pharmacology programs across plasma-derived products, ensures regulatory strategy alignment, and drives pharmacometrics activities within a matrixed R&D environment.

The successful candidate will guide project progression from entry to development and lifecycle management, interacting with global teams and regulatory bodies. Strong communication and strategic thinking are essential.