Clinical Development Lead - OncologyThe Clinical Development Lead Oncology is responsible for planning and implementation of Clinical Development activities for novel medical value diagnostic solutions in the areas of Chronic Liver Diseases, with a primary focus on a personalized health care project within Liver fibrosis.Leads critical review of study results, protocol and report generation to support new product developmentWorks with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure appropriate implementation of clinical development strategiesBuilds and maintains collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring operational excellenceMaintain 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 agenciesLeads comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content (without guidance/direction)Advanced degree in Life Science (PhD, PharmD or equivalent degree) or a Medical degree with relevant expertise in the Healthcare Industry and/or academic institutions~3+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or Medical Device development, 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.) Understands agile culture and exhibits an agile mindset. Excellent verbal and written communication, presentation and negotiation skills in fluent English~ Ability to travel required up to 10-15% (can vary per project phase and position)