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Astellas Pharma Preclinical Study Manager in South San Francisco, California

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Preclinical Study Manager opportunity at their Xyphos site in South San Francisco, CA.

Purpose:

The primary purpose of the Preclinical Study Manager is to support members of our research team in the initiation, execution, and management of preclinical studies with contract research organizations (CROs). This position will work primarily in an office setting with R&D teams.

Essential Job Responsibilities:

  • Supports the implementation of pre-clinical models with a solid foundation of pharmacology and toxicology.
  • Oversees preclinical study logistics, including sample handling and shipment, and tracking of timelines, and deliverables.
  • Manages contract research laboratory (CRO) study director and business/scientific partner interactions and conducts study monitoring as needed.
  • Facilitates protocol development, legal contracts for associated studies, and process protocol changes and amendments as appropriate.
  • Assists in the analysis of experimental results and the preparation of slide presentations for stakeholders.
  • Reviews and edits of preclinical study reports, including QA/QC of raw data.
  • Collaborates with other members of the R&D team, with other teams within Xyphos and Astellas.
  • Performs other duties as assigned or special projects as needed.

Qualifications:

Required

  • BS/MS in life science or related scientific discipline. Minimum of 5 - 7 years' experience in management of CRO-based preclinical studies.
  • Previous experience in the review and revision of study protocols and associated contracts. Experience tracking timelines and deliverables.
  • Excellent written and verbal communication skills and expertise in the maintenance and revision of spreadsheets and presentations.
  • Willingness to learn with enthusiasm to be part of the development of a cutting-edge therapy platform.
  • Ability to work independently with supervision and ability to effectively collaborate with other teams; collegiality is a critical attribute.
  • Proven communication, presentation and influencing skills.
  • Highly developed problem solving and risk management/critical thinking skills.
  • Ability to work independently and ability to effectively collaborate with other teams.
  • Excellent work planning, organization, record keeping and attention to detail.
  • Strong work ethic with a passion for working in a fast-paced, dynamic and diverse work environment.

Preferred

  • Experience with cancer immunology research.
  • Knowledge of pre-clinical rodent and non-rodent animal models of cancer including xenografts, genetically modified models, patient derived tumor explants and syngeneic tumor models.
  • Previous experience in the identification and evaluation management of CROs.
  • Experience managing and executing multiple projects.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Category Research and Development

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