Associate Director/Director, Clinical Development
The Associate Director/Director Clinical Scientist will work closely with the SVP of Clinical R&D to design, implement and deliver clinical studies for the Cyteir portfolio. This will include assisting in trial planning, IND submission and execution of new studies as well as the delivery, analysis and finalization of ongoing clinical trials. This individual be responsible for reviewing, interpreting, and reporting clinical study data to guide and support the Company’s future development plans. They will interact with other functional leaders across the company to incorporate all areas of technical expertise into the drug development plan.
- Assist in planning, design and regulatory submission of new clinical studies based on robust understanding of the scientific and clinical rationale. This will include development of the study protocol, ICFs and associated documents.
- Perform study startup, conduct and close-out activities with support of the Clinical Development Lead
- Responsible for quality data capture including review and validation of eCRF design, clinical data review and query resolution
- Interaction and communication with trial sites including responsibility for protocol training and serving as the primary contact for clinical questions.
- Support regulatory interactions including the development of briefing documents, response to inquiries and study level reporting as required.
- Ensuring that study conduct is compliant with ICH/GCP guidelines.
- Assist with the development of clinical sections in the IB, annual reports, and other investigational product documentation.
- Communicating study results with particular attention to the safety, effectiveness and clinical value.
- Assist and collaborate with internal and external stakeholders to develop publications in line with the Company strategy
- Minimum of Bachelor’s degree in relevant scientific discipline; PhD, PharmD, MS or other relevant higher degree is preferred.
- 2+ years of experience as a clinical scientist in oncology drug development with a proven track record of success
- Proficient in ICH/GCP guidelines
- Knowledge and broad understanding of the drug development process
- Experience conducting clinical trials including the writing of study protocols, ICFs and clinical study reports (CSRs)
- Excellent ability to communicate effectively both in writing and through oral presentations