Job Overview Director, Quantitative Clinical Pharmacology Lead, Cambridge, MA. Lead strategic and operational aspects of multiple drug development projects, provide scientific leadership within Global Program Teams, and support portfolio decisions. Core Responsibilities Lead strategic, scientific, and operational aspects of multiple drug development projects, from first in human dosing through life‑cycle management, including dosage selection and causality evidence. Provide portfolio support through program reviews, decision‑making, and best‑practice initiatives. Collaborate with experts in digital health, outcomes/epidemiology, biostatistics, and other data science disciplines. Serve as the ambassador for Quantitative Clinical Pharmacology and Data & Quantitative Sciences to the R&D organization and the scientific community. Draft and execute clinical pharmacology plans, integrating mechanistic and statistical analyses (e.g., M&S). Enable Model‑Informed Drug Development practices and advanced modeling approaches such as QSP and MBMA to inform internal decisions and regulatory interactions. Represent Clinical Pharmacology in regulatory meetings and produce pharmacology summary documents for submissions. Oversee and independently perform PK, PD, pharmacometric analyses, and data interpretation in partnership with DQS and external partners. Maintain high standards for good clinical practice, compliance, and ethics. Provide mentorship, cross‑functional leadership, and potentially manage a sub‑team within a therapeutic area. Participate in Business Development due diligence when requested. Lead infrastructure initiatives and cross‑functional best‑practice initiatives. Demonstrate leadership in societies and consortiums related to clinical pharmacology (e.g., ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, DIA). Education and Experience Pharm D or PhD with ≥8 years of quantitative experience, including exposure to clinical pharmacology /PK‑PD. MS with ≥12 years of quantitative experience, including exposure to clinical pharmacology/PK‑PD. Desired Technical Skills Extensive knowledge in design, analysis, and reporting of clinical pharmacology studies. Specialized expertise in multiple therapeutic areas, development phases, and/or regions. Leadership in scoping and implementing MIDD within projects. Hands‑on expertise in integrating multiple data sources (PK, PD, efficacy, safety, biomarkers, RWE/RWD) for dose selection and trial design. Experience in regulatory submissions (NDA/CTD) or supplemental NDA/CTD. Experience representing QCP in regulatory interactions at major milestones. Strong knowledge of allied fields critical for drug development (statistics, drug metabolism, pharmacology, toxicology, bioanalysis, pharmaceutical science). Ability to evaluate benefit‑risk and influence therapeutic area strategies. Leadership in cross‑functional decision making and quantitative framework utilization. Drive efficiency through innovative processes and methodologies. Accelerate regional development and filings via innovation. Desired Behavioral Competencies Execute QCP deliverables independently and solve complex problems. Deliver high quality and efficiency consistently. Elevate knowledge and enhance capabilities of others. Communicate effectively and influence across teams. Inspire collaboration and commitment. Share success stories and lessons learned. Focus on priorities and deliver on commitments. Location and Work Format Boston, MA. This position is classified as hybrid in accordance with Takeda’s Hybrid and Remote Work policy. Compensation Summary U.S. Base Salary Range: $177,000 - $278,080. U.S. employees may also be eligible for short‑term and long‑term incentives, medical, dental, vision, 401(k) plan with company match, disability coverage, basic life insurance, tuition reimbursement, paid volunteer time, company holidays, and well‑being benefits. Up to 80 hours of sick time, and new hires accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr