Director, Quantitative Clinical Pharmacology (QCP) Lead

Takeda • Boston, MA

22h • Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? 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. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. 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. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. 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. 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.

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).
• 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.

Benefits

• 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
• well-being benefits
• up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees