Associate 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 an Associate 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.

POSITION OBJECTIVES:

PDT BU R&D advances plasma-derived therapies for patients with rare and complex diseases. Takeda sees substantial potential to better address the needs of patients and healthcare providers across immunologic, hematologic, and other complex conditions.

• Works effectively in a highly matrixed environment, collaborating closely with relevant Takeda and PDT BU functions to advance the PDT R&D portfolio.
• Contributes to clinical pharmacology and pharmacometrics strategies that support PDT projects from entry into clinical development through lifecycle management.
• Serves as Clinical Pharmacology Lead and/or Pharmacometrics Lead for PDT projects and supports regulatory submissions and interactions.
• Requires strategic thinking, strong written and verbal communication, and deep expertise in clinical pharmacology and pharmacometrics.

POSITION ACCOUNTABILITIES:

• Represent Clinical Pharmacology on Clinical Study Team, product development team and other multifunctional teams as needed.
• Plan and oversee clinical pharmacology aspects at study/program level (e.g., dose justification, PK/biomarker/immunogenicity measurement strategies, protocol authoring, clinical pharmacology analysis plan authoring, modeling and simulation analysis plan authoring, clinical phase oversight, reporting).
• Design and execute clinical pharmacology plans and modeling and simulation plans to support the development, registration and commercialization of Takeda’s plasma derived products.
• Identify, design, conduct and/or oversee pharmacometrics projects and/or other type of modeling projects to support the program development and regulatory submissions. Responsible for ensuring use of appropriate analytical methods to integrate knowledge of PK, PD, patient characteristics and disease state to optimize dose regimens and study design.
• Contribute to regulatory documents (e.g., Briefing books, Investigator’s Brochures, IND, BLA, Labeling, Regulatory query responses), 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.
• Manage outsourcing activities (e.g., contract requisition, SOW and approval invoices) with operational and scientific oversight.

EDUCATION, BEHAVIORAL COMPETENCIES AND

SKILLS:

• A Ph.D., Pharm D, or equivalent training in pharmacy, pharmacometrics, pharmaceutical sciences, medical, engineering, applied mathematics or related discipline, with 5+ year clinical pharmacology experience in the pharmaceutical industry.
• Hands-on…