Nephrology Clinical Development Leader

**INTRODUCTION**: As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as **Nephrology Clinical Development Leader**: - (contract for one 1 year, with possible extension). Remote/Home Office: upon discussion. The start date is asap or latest 1st of March. **ASSIGNMENT DESCRIPTION**: - 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 - Driving competitive differentiation, innovation and early pipeline activities and develops intellectual property strategy - Developing and managing external development partnerships (industry &x; 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 products and innovative study designs - Permanently optimizes processes to increase quality and efficiency standards - Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first - Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity - Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial - Model Roche's values of integrity, courage, and passion (culture, mindset and behaviors) **REQUIRED PROFILE**: - 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 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 - Strong business acumen; has in-depth knowledge of the multidisciplinary functions involved in a company's development process, e.g., clinical operations, biostatistics, regulatory, commercial, etc. and can proactively integrate multiple perspectives into the clinical development process and strategy for best end-results - Excellent verbal and written communication, presentation and negotiation skills (English) - Excellent analytical skills and strategic mindset - Ability to work independently **Application process**: Interested? You can find more information here: