GlobalClinicalDevelopmentManager

**Job Description Summary** Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Supports the timely, high-quality initiation of CRO collaboration and successful completion of the assigned clinical development program(s). Provides medical support to the design, execution and reporting of assigned clinical trials and is responsible for the medical oversight on CROs' performance. Drives alignment of non-clinical development with clinical development. Must be willing and capable to deputize for GPMD at GPT. Supports the sGCDM/GPMD in strategic biosimilar development from a clinical perspective, starting with candidate selection, driven by in-depth analyses on risks, value and strategic fit of assets within portfolio management, followed by consecutive stages of program maturation, in collaboration with CRO and respective internal disciplines throughout clinical development, submission and life cycle management. May deputize for the sGCDM/GPMD in corresponding activities. **Job Description** **Major accountabilities: ** * Contributes to the regulatory strategy of the clinical development program and can be assigned as co-author of the Clinical Development Plan. Contributes to the design, conduct, monitoring and reporting of clinical trials in close collaboration with the CRO. Provides clinical research expertise and medical expertise as needed. * Oversees generation of clinical study protocols (Phi and Phlll/ adaptive trials) by CRO and warrants compliance with strategic study concept sheet/synopsis, clinical practices, state of the art development methodologies and regulations in order to produce scientifically sound and conclusive results. * Involved in monitoring clinical trial c