Director, Quantitative Clinical Pharmacology Lead

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Job Description

Are you looking for a patient-focused innovation-driven company that will inspire you and empower you to shine Join us as Director Quantitative Clinical Pharmacology (QCP) Lead in our Cambridge MA office.

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

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.

OBJECTIVES:

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. Has 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 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.
• Mentors junior staff to promote scientific excellence and individual achievement.
• Participates as a member of Business Development due diligence when requested.
• Contributes to 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.

EDUCATION BEHAVIORAL COMPETENCIES AND SKILLS:

Education & Experience

• 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
• Preference will be given to candidates with experience in oncology drug development.

Technical skills:

• Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies.
• Formulates and executes clinical pharmacology plans including integration of MIDD principles.
• Advanced knowledge of pharmaceutical industry overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics Statistics Drug Safety Clinical Sciences Outcomes Digital Health Pharmaceutical Sciences/Device and Global Regulatory Affairs.
• Advanced knowledge of regulatory guidance for industry applicable to the design analysis of clinical trials and process for regulatory submissions across difference regions (ICH FDA EMA and others).
• Advanced knowledge and/or hands-on applications in integration of PK PD efficacy and safety data from multiple sources for dose selection and decision-making.
• Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics.
• Scientific understanding of biological translation drug development and its integration into the clinical pharmacology/pharmacometrics strategy.

Behavioral competencies:

• Independently works by delivering and prioritizing QCP activities across projects with minimal supervision.
• Effectively drives and influences project teams towards objectives while enabling and making decisions.
• Focuses on priorities and delivers on commitments.
• Strong communication skills and ability to translate effectively across functional lines.
• Possess collaborative mindset inspire teamwork and is effective at building alliance across functions.
• Assess benefit/risk of options.
• Develop understanding of business beyond QCP/Pharmacometrics.

This position is currently classified as hybrid in accordance with Takedas Hybrid and Remote Work policy.

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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.

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EEO Statement

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.

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