Clinical Science Director, Early Clinical Devel...
In Cardiovascular, Renal & Metabolism, we are investigating the drivers of CVRM disease progression through ground breaking scientific methods and data-driven drug discovery and development approaches. In this context, the Translational Science and Clinical Development team are investigating a wide range of different drug modalities from a rich CVRM portfolio across cardiovascular, kidney and metabolic disease patient populations.We are looking for an experienced scientist with clinical and/or translational research experience in metabolic disease and obesity. Your ambition to improving patients’ lives will involve you in a team working in a multidisciplinary environment, driving the translational and clinical development of novel innovative therapies in CVRM diseases. In this role, you will have the opportunity to work at the forefront of early clinical and translational research.What You’ll DoAs a clinical and translational scientist, your core accountability will be scientific support for the scientific and translational science development and execution of clinical strategies based upon your established expertise including the latest thinking about mechanisms of disease, diagnostic approaches, current treatment options, drug development trends, and regulatory requirements in relevant disease and therapeutic areas. You will contribute to pre-clinical and early phase clinical trials and related clinical research projects for potential therapies that are targeting metabolic diseases, as well as serving as an expert on the translational human target validation, clinical design, document generation, conduct, monitoring, data interpretation, and reporting of these studies. Additional tasks include supporting regulatory documentation, liaison with discovery scientists, regulatory, clinical and commercial colleagues, developing and managing external collaborations, and developing a deep knowledge of the literature pertaining to the products under development. You will also work on cross-functional teams within our early clinical development group and across the broader early CVRM organization that are framing our strategies and development plans for potential therapies that are targeting major metabolic disorders, given that these disorders intersect with cardiovascular and kidney diseases and influence disease progression.Basic Qualifications
- Ph.D with minimum of 5 years of experience in clinical or translational research in cardiovascular, metabolic, or kidney disease
- Experience in biomarker evaluation, human target validation, or translational science knowledge
- Proven experience in writing clinical synopsis/protocols, regulatory materials and clinical study supporting documents
- Experience in assisting in the design and execution of clinical studies as well as researching patient characteristics, treatments and care
- Demonstratable clinical scientific knowledge in either cardiovascular, metabolism and/or kidney disease
- Good publication track record
- Track record of strong delivery focus, excellent communication skills and ability to collaborate successfully on global cross-disciplinary teams
- Advanced Masters or doctoral degrees
- Experience working in an early clinical trial/research setting within the pharmaceutical industry including preparation of documents supporting clinical trials.