Senior Director, Quantitative Clinical Pharmacology Lead

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Objective / Purpose:

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.

Accountabilities:

• 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&M).

• 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 subteam within a TA and establish TA strategies.

• Demonstrates leadership in scientific societies and cross-industry consortiums related to the clinical pharmacology discipline.

Education & Competencies (Technical and Behavioral):

Desired education qualifications and equivalencies and desired minimum years industry experience:

• Pharm D. or PhD with 12 years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD

• MS with 15 years working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD

Desired technical skills:

• Established Subject Matter Expert in multiple areas internally or externally including leadership of one or more internal or external focus groups.

• Extensive knowledge and experience with design analysis and reporting of clinical pharmacology studies.

• Extensive experience in late-state drug development regulatory submissions (global submission experience preferred) and life-cycle management including pediatric drug development.

• 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.

• Strategizes and oversees 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.

• Drives innovative and/or optimal clinical pharmacology strategy and influences business-critical decision-making beyond QCP responsibilities.

• Drives for efficiency and cost effectiveness using innovative processes and methodologies or by building internal capabilities.

• Ability to evaluate benefit-risk associated with project/asset/franchise and TAU decisions and effectively manage GPT expectations.

• Influences regional regulatory policy and accelerate regional development and filings through innovation (regional QCP)

• The ability to establish external networks to facilitate collaborations across industry government and academia.

• Knowledge and use of AI tools including Copilot

Desired behavioral competencies:

• Provides scientific and strategic leadership.

• Mobilizes high performance teams.

• Influences beyond QCP and DQS.

• Effective communication including influencing others negotiation skills and managing conflicts in teams & TA.

• Prioritizes and delegates.

• Energizes the organization and prepares for the future.