Meet has partnered up with one of their key client based in the Bay Area. They have a robust pipeline working various indications including oncology, neurology and metabolic therapeutic areas. They have one marketed and commercialized product in the metabolic space, looking drive forward more early development products to commercialization.
They're looking for a Director, Clinical Science to own their early development trials focused in endocrinology and work directly with their Senior Director, Clinical Development.
•Design, oversee, and execute clinical deliverables in support of CDP including document development (INDs, Protocols, IBs, applicable regulatory documents, etc.), medical and scientific input into the development of deliverables required for study activation and study conduct (CRFs, SAP, data listings, etc.), data review process, and other deliverables as needed
•Lead and collaborate on the design, conduct, reporting, and analysis of clinical studies.
•Organize and perform study level and individual subject level analysis of clinical trial data to gain insights and develop strategies for clinical development and reporting.
•Attend and contribute, as needed, at meetings with Health Authorities (HAs) related to program; develop responses to HAs and IRBs on clinical/medical questions.
•Develop and optimize an effective KOL and investigator network to support the CDP.
•Work with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are scalable and fit for purpose.
•Mentor, coach, and manage other clinical scientists based on future organizational structure and business needs.?
•PhD, PharmD, or other relevant advanced degree in a health science field preferred, equivalent combination of relevant education and experience may be considered.
•10+ years of biotech or pharmaceutical industry experience with at least 5 years of experience as a clinical scientist or in a related clinical development function
•Experience in immunology clinical trials required, early clinical development and phase I protocol writing experience.
•Demonstrated ability to evaluate, interpret, and present complex scientific data, deep knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.