Nephrology Clinical Development Lead
vor 1 Woche
**Nephrology Clinical Development Lead 5110 SS SRS**
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.
The nephrology clinical development lead is responsible for **planning and implementation of clinical development activities** for assigned products in nephrology. You will **design and implement a diagnostic strategy** for nephrology, in close coordination with the pharma division. Activities will **predominantly focus on the disaggregation of diabetic kidney disease,** early response **markers **of renally active molecules and **strategies** for identification of fast progressors.
**Main Responsibilities**:
Building and maintaining strong, collaborative relationships with cross-functional leaders across Pharma and Diagnostics
Preparing and leading advisory boards within nephrology
Driving competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy
Leading clinical study design and execution, including critical review of study results, protocol and report generation to support new product development
Leading comprehensive literature reviews, supervises collation of relevant clinical and scientific information from different sources, and creates new scientific content
Leading medical/scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies
Maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation
Driving patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
**Qualifications and Experience**:
**Relevant Swiss working/residency permit or Swiss/EU-Citizenship required**;
Medical degree or advanced degree in Life Science with relevant expertise in the Healthcare Industry and/or academic institutions
7+ years academic, diagnostics or pharma industry experience, preferably, having experience in IVD or medical device study management in all stages of global studies, development of study protocol design, report writing and leading matrixed teams
Experience in nephrology research or clinical development
Ability to lead clinical development studies/programs
Good knowledge in applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, FDA,NMPA regulations etc) and understanding of the healthcare industry or equivalent academic experience
Strong business acumen; e.g., clinical operations, biostatistics, regulatory, commercial, etc.
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