Duration: 12 months/possible extension
Location: Rotkreuz
Full time, Hybrid
Responsibilities:
Serve as a subject matter expert for Liver Oncology, clinical study design and evidence generation strategies for internal and external stakeholders in the assigned indication area.
Responsible for critical review of study results, protocol and report generation to support new product development.
Works with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure appropriate implementation of clinical development strategies.
Builds and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellence.
Act as an ambassador and representative of Clinical Development establishing effective collaborative relationships with key functions for new and existing products, incl. clinical utility, intended use and claim extensions.
Play a leadership role in maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation. Leads medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies.
Drives competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy.
Responsible for comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance/direction).
Demonstrate leadership skills; ability to mentor and provide an environment for personal and professional growth.
Must Haves:
Medical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree) with relevant expertise in the Healthcare Industry and/or academic institutions
Min. 2-3 years of industry experience after PhD or coming straight from the industry with at least 5+ years of experience in IVD
Strong experience in liver Indication (Fibrosis and/or Liver cancer)
Min. 5+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or Medical Device development in all stages of global studies, development of study protocol design, report writing and leading matrixed teams
Ability to lead clinical development studies/programs and good knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA, NMPA regulations etc.) especially in global studies in the US and negotiation with the FDA
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