Clinical Development Lead - Oncology m/f/d, ZugThe 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.
Your responsibilities: - Serve as a subject matter expert for Liver Fibrosis and Oncology, clinical study design and evidence generation strategies for internal and external stakeholders in the assigned indication area. Leads 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 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
- Maintain 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
- Leads 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: - 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.) and understanding of the healthcare industry or equivalent academic experience
- Understands agile culture and exhibits an agile mindset. Embraces the VACC (Visionary, Architect, Coach, Catalyst) principles, fosters excellence and enables a productive and collaborative work environment.
- Excellent verbal and written communication, presentation and negotiation skills in fluent English
- Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.
- Excellent analytical skills and strategic mindset. Ability to work independently.
- Ability to travel required up to 10-15% (can vary per project phase and position)
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