Director, Quantitative Clinical Pharmacology (QCP) Lead

Takeda Pharmaceutical Company • Cambridge, MA

127d • $174,500 - $274,230 • Remote

About The Position

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 pharmacology & translational sciences, statistics, programming, outcomes research and epidemiology, and patient safety & pharmacovigilance) 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 QPTS, 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 other functional experts such as DMPK&M, TB&B, and Pharmacometrics to drive a MIDD path within each project, ensuring that mechanistic understanding through systems pharmacology and biomarker insights informs clinical development strategies.

Requirements

• Pharm D. or PhD with 8+ years of working experience in a quantitative field with some exposure to clinical pharmacology.
• MS with 12+ years' working experience in a quantitative field with some exposure to clinical pharmacology.
• 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 with translational studies, disease-relevant models, and biomarker plans to support clinical translation and early clinical development strategy.
• 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 for efficiency using innovative processes and methodologies.

Nice To Haves

• Independently executes QCP deliverables and provides solutions to complex issues.
• Consistently delivers with high quality and efficiency.
• Elevates knowledge and enhances 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

• 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.
• Drives the integration of biological, pharmacological, and clinical insights and possesses primary responsibility for dosage selection and generation of causality evidence across the drug development continuum.
• Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives.
• Explores and excels in synergistic relationships with experts in translational sciences, digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.
• Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.
• Collaborates cross-functionally with discovery, toxicology, and other QPTS functions to ensure that preclinical findings are effectively translated into clinical biomarker plans and exploratory endpoints.
• 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 is 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 DSI 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.

Benefits

• Base Salary Range: $174,500.00 - $274,230.00
• Eligible for short-term and/or long-term incentives.
• Eligible to participate in medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Eligible to receive up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree