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Global Head, Quantitative Clinical Pharmacology in Boston, Massachusetts

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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 Global Head, Quantitative Clinical Pharmacology, 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 OBJECTIVE:

  • As Global Head for Quantitative Clinical Pharmacology, the incumbent will have ultimate responsibility for all clinical pharmacology and pharmacometric plans and studies from preclinical translation through registration and commercialization. They will oversee a therapeutically-aligned group of PhD-level clinical pharmacologists who will work with project teams to devise the quantitative clinical pharmacology/pharmacometrics strategy that encompasses both regulatory and innovative considerations to enable getting good drugs to patients faster.

  • They will ensure technical excellence, deep scientific rigor and operational effectiveness within quantitative clinical pharmacology by empowering the clinical pharmacology leads, participating in/leading relevant governance reviews, building external partnerships and collaborations, encouraging publications, working with the Takeda operating model and managing portfolio risks & priorities.

  • They will work collaboratively with the other quantitative disciplines within the Data Sciences Institute to enhance model-informed drug development, trial design and translational sciences, integration of all available data to inform decisions (including clinical trial, literature, real world data, digital streams) bringing the best of quantitative clinical pharmacology and pharmacometrics principles forward.

POSITION ACCOUNTABILITIES:

  • Develop, manage and build a world-class quantitative clinical pharmacology organization that has the expertise to span across the entire life cycle, across multiple therapeutic areas, across multiple geographical registrations and across multiple modalities.

  • Develop clear expectations regarding the responsibilities and impact of quantitative clinical pharmacology within Takeda project teams and within the Data Sciences Institute.

  • For preclinical stage assets, work collaboratively with other translational colleagues (preclinical pharmacokinetics and drug metabolism, systems modelling, biology, genetics, clinical sciences etc.) to select appropriate biomarkers and to devise appropriate methods and models for dose prediction, design of first-in-human studies, decision criteria for early clinical studies and integration of available disease/genetic/pharmacokinetic/pharmacodynamic data.

  • For clinical assets, use all available methods, models, data and tools to ensure appropriate dose selection across populations and disease states including (but not limited to) exposure-response modelling, PKPD modelling, longitudinal disease modelling, trial simulations.

  • Collaborate to enable fit-for-purpose model-informed drug development across the life cycle to increase probability of technical success, improve confidence in decision-making, decrease time or decrease patient burden and/or numbers, and assess candidate attributes against available or emerging competitive therapeutics.

  • Responsible for the characterization of the clinical pharmacology profile of early and late stage assets, including phase 1 study responsibility for drug interactions, thorough QT and special populations.

  • Responsible for the integrity and correctness of analysis, interpretation and appropriate integration of clinical pharmacology data from development programs and clinical studies longitudinally and cross-sectionally in support of all regulatory submissions, including global filings.

  • Ensures infrastructure (software, methods, processes, vendors, partners etc.) is efficient and meets all required standards.

  • Manage resources, strategically balancing internal vs external work packages, within budget whilst planning for future needs and capabilities

  • Embraces innovation into clinical pharmacology strategy, including application of advanced analytics (machine learning, artificial intelligence), inclusion of novel data sources (real world data, digital streams, literature-derived data, patient reported outcomes) and development of automation.

  • Serves on senior cross-functional strategic and scientific teams and task forces, providing overall clinical pharmacology expertise where required.

  • Enhances Takeda’s reputation externally through scientific leadership and collaboration both within and beyond clinical pharmacology

  • As a member of the leadership team for the Data Sciences Institute, helps drive DSI strategy and accountability across multiple functions ensuring alignment with overall R&D strategy

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • PhD, PharmD, MD, or MD/PhD in a relevant health sciences discipline, with in-depth medical knowledge of physiology, pharmacology, and disease pathophysiology, as well as broad-based knowledge of quantitative clinical pharmacology related areas such as statistics, PK/PD, and systems pharmacology required

  • Recognized leader in the field of quantitative clinical pharmacology and application of computational PK/PD modeling and simulation tools to disease processes and pathophysiology required (as evidenced by publication in peer-reviewed journals)

  • Direct experience with global regulatory submissions and label negotiations.

  • Prior direct experience as Vice President, Executive/Senior Director or other management/leadership positions of Clinical Pharmacology, Pharmacometrics (or similar) in the pharmaceutical industry

  • Minimum 15 years biopharmaceutical/CRO health-related consulting company/academic industry clinical development experience

  • Membership in appropriate professional organizations.

  • Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage teams to maximize the organizational productivity

  • Has strong leadership skills and acumen.

  • Has excellent written and verbal communication skills

  • Has a proven track record in successfully developing and implementing business strategies.

Location and Salary Information:

Base Salary Range: $237,300 to $339,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.”

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • Health & Wellness programs including onsite flu shots and health screenings

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs

Empowering Our People to Shine

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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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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