Manager, Quantitative Clinical Pharmacology Lead

About the Role

Takeda is a global, values-based, R&D-driven biopharmaceutical leader committed to discovering and delivering life-transforming treatments. The Data and Quantitative Sciences (DQS) group comprises over 500 quantitative scientists who utilize data and digital insights to accelerate the development of innovative treatments. Within DQS, the Quantitative Clinical Pharmacology (QCP) Team focuses on driving clinical pharmacology strategy from pre-FIH through life-cycle management. The QCP role partners with the pharmacometrics lead to advance model-informed drug development (MIDD).

How You Will Contribute

• Provides clinical pharmacology support at the study or project level.
• Holds primary responsibility for dosage selection and generation of causality evidence.
• Offers additional portfolio support through program reviews, collaborative decision-making, infrastructure, and best practice initiatives.
• Explores and fosters synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador for QCP and DQS to the R&D organization and the external scientific community through participation at scientific meetings and publications.

Key Responsibilities

• Provides study-level support to assigned projects with some supervision.
• Creates or assists in the preparation of protocol synopses.
• Oversees program execution, including protocol conduct, data analysis, and reporting.
• Contributes to clinical pharmacology content in regulatory submission documents (e.g., briefing book, IB, IND, CTA, CTD Module 2, CCDS, product labeling).
• Oversees and/or independently performs PK, PD, or pharmacometrics analyses, including interpretation of PK/PD data, in partnership with DSI and external partners.
• Participates in activities supporting QCP strategies and mission.
• Maintains high standards for good clinical practice, compliance, and ethics.
• Mentors junior staff to promote scientific excellence and individual achievement.
• Participates as a member of Business Development due diligence when requested.
• Contributes to infrastructure and/or cross-functional best practice initiatives.
• Influences scientifically outside QCP and Takeda through presentations, publications, and contributions to scientific societies and cross-industry consortiums related to clinical pharmacology (e.g., ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA).

Requirements & Tech Stack

• General knowledge in the application of PK/PD, Modelling and Simulation, and the use of clinical biomarkers and quantitative decision making.
• General understanding of clinical pharmacology study designs, common analysis methods (e.g., NCA, Compartmental, PK-PD), basic statistics, and working knowledge of common analysis software.
• Basic knowledge of the pharmaceutical industry, including the clinical drug development process and associated disciplines.
• Basic knowledge of regulatory guidance for industry applicable to clinical trials and regulatory submissions across different regions (ICH, FDA, EMA).

Qualifications

• Pharm.D. or Ph.D. with 0-2 years of working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.
• M.S. with 3+ years of working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD.

Desired Behavioral Competencies

• Owns assigned tasks and actively seeks input from others.
• Eager to learn and demonstrate interest in scientific development.
• Excellent oral and written communication skills.
• Ability to introduce new ideas and improve existing approaches.
• Delivers on commitments.