Senior Director, Quantitative Clinical Pharmacology Lead

As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project.

Position Objectives

• Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management.
• Possesses primary responsibility for dosage selection and generation of causality evidence.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
• Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data and Quantitative Sciences (DQS) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
• Provides scientific and strategic leadership as the global or regional Clinical Pharmacology Lead for multiple projects in translational/clinical/post-marketing stages.
• Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).
• Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions.
• Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions.
• Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DQS and external partners.
• Maintains a high standard for good clinical practice, compliance, and ethics.
• Participates as a member of Business Development due diligence, when requested.
• Promotes and drives the QCP vision and mission, identifies opportunities, and creates delivery for DQS mission to make R&D business impact.
• Provides mentorship to junior staff, acts as a cross functional leader and may manage a TA team or a sub-team within a TA and establish TA strategies.
• Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA.

Education, Behavioral Competencies and Skills

• Pharm D/PhD with 12+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD OR MS with 15+ years' working experience
• Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups.
• Expert knowledge and/or hands-on applications; integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and quantitative decision making.
• Ability to strategize and oversee complex pharmacometrics analyses including developing innovative methodology/solutions and interpretation of PK/PD data in close partnership with pharmacometrics, DQS and other internal and/or external partners.
• Ability to drive innovative and/or optimal clinical pharmacology strategy and influences business-critical decision-making beyond QCP responsibilities.
• Ability to evaluate benefit-risk associated with project/asset/franchise and TAU decisions and effectively manage GPT expectations.
• Extensive experience in global filings and approvals or interactions with global regulatory experience for development strategy and submission plan.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work.