At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
The Director/Senior Director of Clinical Science will oversee one or more clinical development programs. This individual is responsible for the planning and execution of clinical studies to move programs from IND/CTA through to later stage trials. This individual will work closely with cross-functional teams to develop innovative and efficient solutions to medical and scientific clinical trial issues, and in ensure the successful design, analysis, and completion of clinical trials. In addition, this individual will play a leadership role in the Clinical Development team and mentor or manage others in the Clinical Science function.
· 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.
· Perform all duties in keeping with the DICE Therapeutics’ core values, policies, and all applicable regulations.
· 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.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.