Lead Director, Data Management

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Join us as a Director, Quantitative Clinical Pharmacology Lead 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. 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. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. 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. 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. 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 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., 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. 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. 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. Consistently delivers with high quality and efficiency. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. No Phone Calls or Recruiters Please. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. 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. Full time