Director, Quantitative Clinical Pharmacology (QCP) Lead

Takeda•Boston, MA

1d•$177,000 - $278,080•Hybrid

About The Position

Takeda is a global, values-based, R&D-driven biopharmaceutical leader committed to discovering and delivering life-transforming treatments. The company's Data and Quantitative Sciences (DQS) group comprises over 500 quantitative scientists who leverage data and digital insights to accelerate the development of innovative treatments. These scientists, specializing in areas like quantitative clinical pharmacology, statistics, programming, and digital strategy, contribute their expertise to global program teams and explore novel data streams, real-world data, digital tools, and advanced analytics including AI and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team drives the clinical pharmacology strategy from pre-First-in-Human (FIH) studies through life-cycle management within global project teams. The QCP role collaborates with the pharmacometrics lead to establish a Model-Informed Drug Development (MIDD) pathway for each project. This Director-level position involves leading strategic, scientific, and operational aspects of multiple drug development projects with a high degree of technical and strategic independence, from FIH dosing through life cycle management. The role holds primary responsibility for dosage selection and generating causality evidence, while also providing portfolio support through program reviews, collaborative decision-making, and infrastructure initiatives. The Director is expected to foster synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other data science disciplines, and serve as an ambassador for QCP and DQS within the R&D organization and the broader scientific community through participation in meetings and publications.

Requirements

Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD
MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD
Extensive knowledge and experience with design, analysis, and reporting of clinical pharmacology studies.
Specialized clinical pharmacology expertise in multiple therapeutic areas, development phases, and/or different regions.
Experience in leading and driving the scoping and implementation of MIDD within projects.
Hands-on expertise/knowledge in application of advanced knowledge in integration of multiple data sources (PK/PD/Efficacy/Safety/biomarkers/RWE/RWD) across the asset to drive dose selection, optimized trial design, and quantitative decision making.
Experience in regulatory submission and approvals of at least one original/major NDA/CTDs or multiple supplemental NDA/CTDs (global or regional).
Experience in representing the QCP function in interactions with global or regional regulatory agencies at significant development milestones such as EoP2, pre-submission, and pediatric development plan (PIP and PWR).
Strong knowledge of allied fields critical for drug development, such as statistics, drug metabolism, pharmacology, toxicology, bioanalysis, and pharmaceutical science.
Ability to evaluate Benefit-Risk associated with project decisions, effectively manage GPT expectations and influence TA strategies.
Leadership in cross functional decision to optimize the likelihood of drug R&D success and utilization of the quantitative decision-making framework.
Drives efficiency using innovative processes and methodologies.
Accelerates regional development and filings through innovation (regional QCP).

Nice To Haves

Independently executes QCP deliverables and provides solutions to complex issues.
Consistently delivers with high quality and efficiency.
Elevates knowledge and enhances the capability of others.
Communicates effectively and influences in cross-functional teams.
Inspires commitment and enables cross-function collaboration.
Communicates success stories and shares learning across QCP.
Focuses on priorities and delivers on commitments.

Responsibilities

Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams.
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.
Provides mentorship to junior staff, acts as a cross functional leader and may manage a sub-team within a TA.
Participates as a member of Business Development due diligence, when requested.
Leads infrastructure initiatives and/ or cross-functional best practice initiatives.
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.