Skip Navigation
Japanese Returning User Login Corporate Website
Menu

Senior Director, Quantitative Clinical Pharmacology

 

Success Profile

What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix

Animated Graph

Engage Others Motivates and influences others to gain support for ideas, strategies and actions in service to providing superior pharmaceutical products to patients; provides appropriate background so that messages are meaningful with audiences.

Collaboration Establishes productive relationships and partners with others across the organization to ensure common understanding of objectives and achieve shared goals.

Drive for Results Holds self and others accountable for delivering on commitments that align with our short- and long-term goals, never forgetting the end result is to help patients through innovation in medicine.

Strategic Approach Makes sound decisions that are consistent with our mission, values and organizational objectives.

Lead Change Proactively evaluates, promotes, and initiates change that creates value for patients, the organization, and our shareholders.

Self Awareness Seeks feedback from others, modifies self-perceptions and actions based on this feedback, and actively develops skills and behaviors to enhance contribution.

Develop Capabilities Seeks opportunities to develop oneself and others so that we can continue to achieve sustained growth.

Rewards

  • Teamwork

    Takeda builds strong, borderless and empowered teams through fairness and promoting shared goals. By working together, we optimize energy and can lead the change for a better world.

  • Innovation

    Takeda implements bold initiatives on a daily basis by striving for continuous improvement and encouraging enthusiasm and creativity. This value speaks to attracting the best minds in the industry that are committed to delivering novel therapies to patients worldwide.

  • Diversity

    Takeda respects and includes a broad range of people and ideas in its daily operations. Our organization encourages each individual to act with empathy and to apply their unique skills to realize the company’s true potential.

  • Passion

    Takeda's drive comes from perseverance, urgency and a strong desire to contribute to patients. We put this passion to work in everything we do and demonstrate courage to fight for ideas and objectives to raise the quality of our solutions, create stronger ties with our stakeholders, and deliver results.

  • Commitment

    Takeda works to meet its responsibilities to stakeholders on a daily basis. We provide adequate support and challenge to ensure we deliver high-quality solutions that help more people around the world.

  • Transparency

    Takeda appropriately shares information and promotes honest, sincere dialogue with stakeholders to build trust. This trust enables us to strengthen our relationships with employees and external communities.

Videos

  • Takeda Oncology

  • Inspired by Patients

  • Corporate Citizenship Activities

News and Events

  • Moving Mountains

    Moving Mountains My Story and Why I’m Climbing
    I oversee Corporate Communications at Takeda Oncology, a company committed to discovering and developing treatments for patients with cancers

    Moving Mountains
  • One Vision: We aspire to cure cancer.

    Takeda Completes Acquisition of ARIAD Pharmaceuticals, Inc., significantly enhancing our global oncology portfolio and reinforcing our commitment to develop medicines for patients living with cancer.

  • Our communities

    Rushing Toward a Cure (RTC) launched in 2006 in partnership with the Patriots Radio Network (WBZ 98.5) and our local chapter of the Leukemia & Lymphoma Society (LLS). With RTC, Takeda Oncology contributes a set financial donation to the LLS for every 100 rushing yards gained by New England during the pre, regular and post-seasons. This money helps fund vital blood cancer research, patient services and education programs.

Overview

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, central nervous system and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Takeda Pharmaceuticals U.S.A., Inc. ranks among the top 15 pharmaceutical companies in the United States. Our larger U.S. offices are in Cambridge, MA, Deerfield, IL, and San Diego, CA. Research & Development employees in our Cambridge location focus on oncology, gastroenterology, immunomodulation, biologics, translational research, and external innovation. In March 2016, we opened our newest space at 300 Massachusetts Avenue, featuring 230,000 square feet of state-of-the-art office and lab space.

While Takeda is enjoying tremendous growth as an emerging global leader in the pharmaceutical industry, we remain ever mindful of our commitment to serve people worldwide by striving toward better health through leading innovation in medicine. In short, we are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

Responsibilities

OBJECTIVES:
  • The Senior Director, Marketed Products in QCP is responsible for providing the clinical pharmacology strategy necessary to fulfill the marketing authorization holder obligations for all marketed products.
  • Responsible for overseeing and managing clinical pharmacology activities for all marketed products by relying on external resources.
  • Serves as the functional link between QCP and the Marketed Products Group (MPG), ensuring that QCP and TREC leadership are fully aware of all MPG activities related to clinical pharmacology.

ACCOUNTABILITIES:

  • Represents QCP in the MPG, serving on all GPTs and EPSTs for marketed products.
  • Responsible for providing clinical pharmacology strategy for all marketed products, ensuring technical and scientific activities for these programs meet state of the art industry standards. 
  • Serves as Takeda’s internal point person for clinical pharmacology work for marketed products performed by external partners/vendors. Oversees and monitors study-level clinical pharmacology support for marketed products, including preparation of the protocol, study conduct, as well as analysis, interpretation and reporting of the study data.
  • Oversees and monitors the development and implementation of the bioanalytical chemistry strategy for marketed products, including vendor selection, oversight of assay development or transfer, validation, and analysis of the samples.
  • Utilizes existing QCP and TREC business activities to ensure that all clinical pharmacology studies and activities for marketed product are appropriately peer-reviewed and meet the requirements of QCP and TREC management oversight.
  • Critically reviews and provides strategic input on all global regulatory documents necessary to support marketed products.
  • Represents Takeda in negotiations and at meetings with global regulatory authorities for any clinical pharmacology related matter, including labeling requirements, studies to support market expansion, as well as studies to fulfill marketing authorization requirements such as PK/PD studies to support pediatric registrations and registration of new formulations.
  • Works closely with other functional experts across TREC and the broader R&D organization, such Regulatory Affairs, Clinical Science, Pharmaceutical Science, TBR, and QS in providing leadership and guidance in clinical pharmacology activities for marketed products.
  • Maintains a high standard for good clinical practice, compliance and ethics.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Represents QCP in the MPG, serving on all GPTs and EPSTs for marketed products.
  • Responsible for providing clinical pharmacology strategy for all marketed products, ensuring technical and scientific activities for these programs meet state of the art industry standards. 
  • Serves as Takeda’s internal point person for clinical pharmacology work for marketed products performed by external partners/vendors. Oversees and monitors study-level clinical pharmacology support for marketed products, including preparation of the protocol, study conduct, as well as analysis, interpretation and reporting of the study data.
  • Oversees and monitors the development and implementation of the bioanalytical chemistry strategy for marketed products, including vendor selection, oversight of assay development or transfer, validation, and analysis of the samples.
  • Utilizes existing QCP and TREC business activities to ensure that all clinical pharmacology studies and activities for marketed product are appropriately peer-reviewed and meet the requirements of QCP and TREC management oversight.
  • Critically reviews and provides strategic input on all global regulatory documents necessary to support marketed products.
  • Represents Takeda in negotiations and at meetings with global regulatory authorities for any clinical pharmacology related matter, including labeling requirements, studies to support market expansion, as well as studies to fulfill marketing authorization requirements such as PK/PD studies to support pediatric registrations and registration of new formulations.
  • Works closely with other functional experts across TREC and the broader R&D organization, such Regulatory Affairs, Clinical Science, Pharmaceutical Science, TBR, and QS in providing leadership and guidance in clinical pharmacology activities for marketed products.
  • Maintains a high standard for good clinical practice, compliance and ethics.

PHYSICAL DEMANDS:

  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • Access to transportation to attend various meetings held in proximity to the Takeda offices.
  • Able attend meetings at investigator, vendor or regulatory agency sites.
  • Some international travel may be required.

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule

Sign Up for Job Alerts

Sign Up

Select Your InterestsSearch for a category and select one from the list of suggestions. Search for a location and select one from the list of suggestions. Finally, click “Add” to create your job alert.

  • Research and Development, Cambridge, Massachusetts, United StatesRemove

Current employees click here >