4 days old

Clinical Research Scientist

Danaher
Sunnyvale, CA 94086

ESSENTIAL JOB RESPONSIBILITIES:

  • Provide scientific input on clinical trial design and management of strategies for obtaining clinical evidence using the product evidence strategy plan process (PESP) Develops strategies for clinical trials for US, EU and/or rest of world registration studies as determined by business priorities
  • Scientific oversight for clinical trial strategy, clinical trial protocol development and clinical trial reports for China FDA registration studies. 
  • Collaborates with a multidisciplinary team in the development, creation and execution of clinical trial protocols
  • Establishes scientific methods for designing clinical trial study protocols 
  • Prepares scientific content of clinical study reports 
  • Review both clinical and analytical sections for regulatory submissions
  • Develops good collaborations with scientists, internally and externally
  • Has and maintains scientific, technical and clinical expertise in oncology especially with respect to molecular diagnostics
  • Review pertinent literature, prepares white papers/manuscripts, and provides education to Cepheid staff as needed.
  • Provide scientific support by interpreting safety and efficacy results data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
  • Ensures clinical data meets all necessary regulatory standards
  • Collaborate cross-functionally with Government Affairs, Medical and Scientific Affairs on PESP
  • Ensure that activities are conducted in compliance with current applicable regulations, laws and guidance including but not limited to US, EU and China regulations as well as with Cepheid€™s policies and procedures

    TRAINING RESPONSIBILITIES: (REQUIRED)

    • Complete all assigned and required training satisfactorily and on time

      MINIMUM REQUIREMENTS:

      Education and Experience (in years): 

      • Bachelor€™s degree with 2+ years of related work experience OR
      • Master€™s degree in field with 0-2 years of related work experience

        Knowledge and skills: 

        • Experience with in vitro diagnostic (IVD) products (preferably in molecular diagnostics or immunodiagnostics, in oncology) OR Medical Device experience will also be considered.
        • Strong interpersonal, written communication, and presentation skills
        • Good problem-solving skills
        • Performance oriented with ability to work along agreed timelines with a focus on execution

          PREFERRED REQUIREMENTS:

          • A Masters or PhD in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology
          • Strong scientific background with deep understanding of oncology and the molecular diagnostic area
          • Preferred experience in IVDD/IVDR or MDD/MDR regulations  

            Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Biotechnology

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Posted: 2020-05-21 Expires: 2020-06-20

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Clinical Research Scientist

Danaher
Sunnyvale, CA 94086

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