Director, Clinical Pharmacology

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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Clinical Pharmacology in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases.

• This individual will work in a highly matrixed team setting and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to support project goals.
• This individual will contribute to the clinical pharmacology and pharmacometrics strategy to support PDT project progression from entry to clinical development to life cycle management
• This individual will act as the global clinical pharmacology lead on PDT projects and contribute to regulatory submissions and interactions.
• This role requires strong strategic thinking, excellent verbal and written communication skills, and in-depth Clinical Pharmacology and PK/PD knowledge.

• Design clinical pharmacology programs to support the development, registration and commercialization of Takeda’s plasma derived products.
• Represent Clinical Pharmacology on different product development teams. Provides input into all phases of drug development including, but not limited to dose finding, dose optimization, exposure-response, and pediatric development.
• Leads study design, execution and reporting of clinical pharmacology studies
• Identify, design, conduct and/or oversee pharmacometrics projects to support the program progression and regulatory submissions. The relevant pharmacometrics projects may include and are not limited to: non-compartmental PK, PK/PD analyses, population PK and PK/PD, and other modeling and simulation activities as appropriate for the project.
• Contribute to regulatory documents including Investigator Brochures, Labeling and those required for regulatory strategies, interactions and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in writing and reviewing responses to regulatory queries.
• Write/Review Clinical Pharmacology Plans and Reports, as well as relevant sections of CSRs.
• Manage outsourcing activities and approved budget accordingly. Manage contract requisition, SOW and approval of invoices.
• May participate in identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations.

• A Ph.D., Pharm D, MD or equivalent degree with at least 10 years of clinical pharmacology experience within the pharmaceutical industry.
• Educational background in clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or a related field.

• Demonstrated ability to successfully manage the clinical pharmacology/pharmacokinetic components of multiple drug products…