Senior Director, Quantitative Clinical Pharmacology Lead

About the role

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.

About the role

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.

Position Objectives

• 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.
• Provides scientific and strategic leadership as the global or regional Clinical Pharmacology Lead for multiple projects in translational/clinical/post-marketing stages.
• 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.
• Participates as a member of Business Development due diligence, when requested.
• Promotes and drives the QCP vision and mission, identifies opportunities, and creates delivery for DQS mission to make R&D business impact.
• Provides mentorship to junior staff, acts as a cross functional leader and may manage a TA team or a sub- team within a TA and establish TA strategies.
• 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.

Education, Behavioral Competencies and Skills

• Pharm D/PhD with 12+ years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD OR MS with 15+ years' working experience
• Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups.
• Expert knowledge and/or hands-on applications; integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and quantitative decision making.
• Ability to strategize and oversee complex pharmacometrics analyses including developing innovative methodology/solutions and interpretation of PK/PD data in close partnership with pharmacometrics, DQS and other internal and/or external partners.
• Ability to drive innovative and/or optimal clinical pharmacology strategy and influences business-critical decision- making beyond QCP responsibilities.
• Ability to evaluate benefit-risk associated with project/asset/franchise and TAU decisions and effectively manage GPT expectations.
• Extensive experience in global filings and approvals or interactions with global regulatory experience for development strategy and submission plan.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work

Takeda Compensation and Benefits Summary

• We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• For Location: Boston, MA

U.S. Base Salary Range

$212,000.00 - $333,190.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.