Nephrology Clinical Development Lead

Vor 3 Tagen


Zug, Schweiz Coopers Group AG Vollzeit

**Responsibilities**:

- Building and maintaining strong, collaborative relationships with cross-functional leaders across Pharma and Diagnostics, key internal and external stakeholders and other alliance partners, in meeting business goals and ensuring scientific excellence
- Preparing and leading advisory boards within nephrology
- Substantial contribution to the clinical development strategy for nephrology
- Developing and managing external development partnerships (industry & academia)
- Designing scientifically sound clinical studies and study programs in cross-functional teams
- 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
- Participation in external interactions with health authorities (HAs)
- Building and maintaining relationships with international opinion leaders, investigators and key customers, bringing external know-how in-house for the development of new

**Requirements**:

- Medical degree or advanced degree in Life Science
- Minimum 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 is a plus
- 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.



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