Contribute to the success of a serology function assigned to global clinical development programs (e.g. Dengue, Norovirus) within the Vaccines Business Unit (VBU) by managing and overseeing clinical sample handling and testing with clinical assays in contracted laboratories. Ensuring 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 associated governance structures, and carry Clinical Development team message of clinical targets and assay strategy out to larger working group.
- 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 Serology Plans 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.
- 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.
- Drive the drafting and 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 allocated studies.
- 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, 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.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Bachelors Degree or international equivalent in the life sciences with a minimum of 5 years practical laboratory experience. Advanced degree highly desirable with a minimum of 3 years post degree practical laboratory experience.
- Alternatively, advanced degree with a minimum of 3 years demonstrated excellence in project/program management. Preference given for work in the pharmaceutical industry and/or within clinical development.
- Basic understanding of GMP, GLP, GCP-ICH and/or GCLP guidelines. Knowledge of product development processes, preferably in biologics and/or vaccines.
- 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).
- 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.
- Fluent spoken and written English.
- Readiness to travel internationally and domestically as required.
- Travel requirements estimated between 10-15%.
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