Responsible and accountable for leading gene therapy projects from early discovery research stage to development transition and IND-filing and for delivering development gene therapy candidates to the research pipeline. The incumbent will be empowered to establish and collaborate with the gene therapy research team, disease biology experts and other research and development line function representatives within Takeda to progress gene therapy projects in a highly matrixed and collaborative manner.
- Co-leads and/or participates in cross-functional project teams to represent Gene Therapy Research Team
- Be the scientific researcher and subject matter expert of gene therapy technology.
- Conducts gene therapy research projects with a drug developability perspective.
- Collaborates with other researchers to design and execute experiments in a highly matrixed environment.
- Designs and conducts hands-on experiments, analysis of results, documentation, preparation of study reports and presentations.
- Works effectively with CROs to deliver materials and reagents needed for gene therapy drug development.
- Ensures compliance of Gene Therapy activities.
- Follows compliance of documentation in electronic laboratory notebooks.
- Works effectively with Business Development to help identify and critically assess external opportunities from academic partners and/or biotechs and incorporates them into our portfolio as appropriate.
Education and Experience Requirement:
- Highly motivated researcher with PhD degree and postdoctoral training in virology, pharmacology, genetics, or other life sciences areas.
- Expected to have 5+ years of experience in the biotechnology or pharmaceutical industry, designing, optimizing and delivering high quality gene therapy drug candidates and leading project teams.
- Significant experience managing external CROs.
- Strong track record of scientific publications is required.
- Significant experience and demonstrated scientific leadership with drug discovery and development for viral based gene therapy products.
Key Skills, Abilities, and Competencies:
- Utilizes expertise in vectorology, lab-scale research grade vector production and vector characterization to construct gene therapy vector candidates.
- Designs in vitro and in vivo pharmacology and efficacy studies to test vector candidates and contributes to the development candidate prioritization and selection.
- Project execution would include interacting with the gene therapy research team, disease area SMEs, pharmacology and all other nonclinical development colleagues in the R&D setting within Takeda and occasionally with external partners.
- Hands on experience in genetics to test gene therapy vectors through the design, planning and execution of preclinical proof-of-concept in vivo experiments in normal and various disease animal models with in-depth understanding of end point measurements in collaboration with internal and external team members.
- Develops and establishes new in vitro and in vivo assays for vector characterization and detection of a pharmacological response.
- Ability to independently analyze and present data to project and management teams. Data-driven, critical thinking, analytical and has the ability to interpret results with statistical approaches.
- Utilization of electronic lab notebook to document experimental outcomes and generate study reports for internal use and regulatory submissions.
- Be the subject matter expert of viral-based gene therapy drug product and have direct communication with Pharmaceutical Sciences to assist in the research to development transition.
- Experienced with external facing interactions with academic and/or industrial collaborators, will conduct collaborative projects and due diligence evaluation.
- Excellent interpersonal communication and written skills for presentations, report writing and day-to-day project team communications.
- Exhibit and promote Takeda Core Competencies.
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Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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