Clinical Bioanalysis Project Manager

vor 2 Wochen

Zurich, Schweiz Takeda Pharmaceutical Vollzeit

**People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**.

For our Vaccine Business Unit in Zurich, we are looking for a

**Clinical Bioanalysis Project Manager (M/F/d)**

in a permanent and full-time position.

Contribute to the success of a clinical bioanalysis 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.

**Your tasks in detail (among others)**:

- Support global objectives of Clinical Development and Head of Clinical Bioanalysis 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 Clinical Bioanalysis and Clinical Development in clinical trial group meetings with the responsibility to follow the big picture and know how timeline issues in other groups will impact testing timelines, and proactively inform other stakeholders when testing 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 budget for 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 Operations 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 Clinical Bioanalysis in accordance with regulatory requirements and the Takeda Quality management system.

**Your profile**:

- Bachelor’s Degree or international equivalent in the life sciences with a minimum of 5 years relevant experience, pharma or biotech experience strongly preferred. This experience preferably is inclusive of at least 1 year of practical lab experience and at least 2 years of project management experience. Advanced degree highly desirable including several years of 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 w

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