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Clinical Serology Project Manager (Dengue) - Vaccine Business Unit

 

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

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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

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  • 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.

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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

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.
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!

OBJECTIVES:

Contribute to the success of a serology function assigned to global clinical development programs (e.g. Dengue, Norovirus) within the Vaccines Business Unit (VBU) to coordinate and drive the timely delivery of clinical serology assays through collaboration with Analytical Development, and to manage and oversee clinical sample handling and testing with the clinical assays in contracted laboratories.Responsible for managing sample handling, testing, and reconciliation of sample handling from clinical site to vendor.Ensure timely delivery of quality clinical serology data to assess clinical endpoints in clinical studies, in compliance with Takeda processes and international regulatory and quality standards.Report compliance of timelines to Clinical Development team, and carry Clinical Development team message of clinical targets and assay strategy out to larger working group.

ACCOUNTABILITIES:

  • Support global objectives of Clinical Development and Head of Clinical Serology in VBU in every aspect of clinical sample testing. This includes but is not limited to reviewing clinical trial lab manuals, preparing SerologyPlans to meet the endpoint objectives of each trial, following clinical samples through delivery to bio-analytical vendor, testing, data transfer and long term storage.
  • Actively participate and represent the objectives of Serology and Clinical Development in clinical trial group meetings with the responsibility to follow the big picture and know what impact timeline issues in other groups will impact serology timelines, and also proactively inform other stakeholders when serology timeline changes may impact their activities.
  • Comprehend and translate complicated scientific information in a way that can be utilized by nonscientific members of the clinical trial team.
  • Interpret objectives of other matrix team members in the clinical trial and initiate discussions and collaboration so that what could be conflicting timelines and goals lead to the successful accomplishment of overall study objectives. 
  • This now falls more under the interaction between the Serology Lead and Analytical Development group
  • This now falls more under the interaction between the Serology Lead and Analytical Development group
  • Drive the drafting and responsible for execution of contracts and Work Orders with bio-analytical vendor labs, based on Serology Plans.
  • Oversee and manage the serology budget of clinical sample testing for all studies of the program.
  • Lead sample management for the clinical study beginning with oversight of shipment conditions and timing from the clinical site to the central laboratory, delivery of samples to the bio-analytical vendor, testing, reconciliation, data transfer, and final long term storage or further use approval of clinical samples.
  • Oversee the review and execution of the Lab Manual, provided by the contracted central lab vendors, to guarantee proper sample management. Partner with Clinical Delivery project manager to implement the Serology Plan for the clinical endpoints in studies, in compliance with GCP-ICH guidelines.
  • Inform Quality Assurance team on any quality deviation of sample management and clinical sample testing.
  • Actively collect, interpret and review and document the above quality deviations for clinical sample handling or testing in the appropriate QA system.
  • Oversee all timelines of clinical assays: from the development and validation of assays to the delivery of QC/QA results of clinical sample testing to Statistic and Data management. Provide regular updates to clinical teams on status and timelines.
  • Oversee the trial master file (TMF) documents owned by serology in accordance with regulatory requirements and the Takeda Quality management system.
  • Clearly document any changes to the clinical trial assay plan with analytically interpreted risk management assessment of impact to data and overall clinical trial outcomes.Understanding and ability to communicate justification for changes a high priority.

Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelors Degree or international equivalent in the life sciences required with a minimum of 5 years practical laboratory experience.Advanced degree highly desirable with a minimum of 3 years post degree practical laboratory experience.
  • Minimum 3 years demonstrated excellence in project/program management.Preference given for work in the pharmaceutical environment and/or work with vaccines.
  • Knowledge and understanding of product development processes, preferably in biologics, regulatory pathways for biologics (e.g. FDA, EMA), and knowledge of cGCP, cGLP and cGMP.
  • Proven leadership, team building skills and strategic problem-solving ability. Demonstrated ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions
  • Proven ability to communicate and collaborate effectively with senior management. Experience interacting with external collaborators with ability to build strong relationships.
  • Knowledge of risk management, project reporting, and project management tools.
  • Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead highly technical teams.
  • Excellent organization, verbal and written communication skills to explain project goals and inspire support.
  • Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
  • Demonstrated time-management organizational skills.
  • Experience and demonstrated success in sample testing by using serology assays and other bio-analytical methods. This includes experience and understanding in working with blood borne pathogens and human serum.Preference if this experience also includes assay development, qualification and validation.
  • Background in virology (e.g. flavivirus, alphaviruses, calicivirus) and vaccine development desirable, as well as in immunology and molecular biology.
  • Basic understanding of GMP, GCP-ICH and GCLP guidelines.
  • Understanding of the vaccine development process and experience with the support of clinical trial teams.
  • Fluent spoken and written English.
  • Successful experience in working with globally operating matrix teams and in the coordination of various internal and external interfaces (academia, in-house labs, and contracted vendors).


TRAVEL REQUIREMENTS:
  • Readiness to travel internationally as required.

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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*LI-KB1-VBU


Schedule
Full-time

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