Associate Director/Director, Clinical Scientist in Clinical Development
The Associate Director/Director Clinical Scientist will work closely with the VP of Clinical R&D or study physician to design, implement and deliver clinical studies for the Cyteir portfolio. This will include assisting in trial planning, protocol writing, IND submission, site selection, CRF design, study manual writing, site selection and execution of new studies as well as the conduct, medical monitoring, database locking, data analysis and CSR writing of ongoing clinical trials. This individual will be responsible for reviewing clinical data in real time to assure accuracy and medical consistency, and to identify safety signals. The Clinical Scientist will work closely with the study physician to interpret and report clinical study data to guide and support Cyteir’s future development plans. The Clinical Scientist will interact closely with clinical operations to assure timely completion of study timelines, and work 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 or review of the study protocol, ICFs and associated study documents.
- Perform site selection, study startup, medical monitoring, safety review and close-out activities with support of the study physician
- Responsible for oversight of quality data capture including review of eCRF design, monitoring plans, and auto-query design
- Performs ongoing review of trial data to evaluate data trends, safety signals, endpoint outcomes and protocol adherence issues.
- Writes queries to resolve inconsistencies in CRF data entry
- Interaction and communication with trial sites including responsibility for assisting with protocol training and answering patient eligibility and clinical questions.
- Support regulatory interactions including the development of briefing documents, response to inquiries and study level reporting as required.
- Assist with the development of clinical sections in the IB, annual reports, clinical study reports and other investigational product documentation.
- Communicating study results to internal teams and external partners with particular attention to the safety, effectiveness, and clinical value.
- Update the management team with dashboards on the trial status on the trial(s) supported
- 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.
- 3+ years of experience as a clinical scientist in oncology drug development with a proven track record of success
- Proficient in ICH/GCP guidelines
- Familiarity in SAE reporting requirements
- Knowledge and broad understanding of the drug development process
- Experience conducting clinical trials including the writing of study protocols, ICFs, study manuals, design of CRFs and writing of CRF completion guidelines, medical monitoring plans and clinical study reports (CSRs)
- Excellent ability to communicate effectively both in writing and through oral presentations
- Experience preparing and responding to regulatory documents from the FDA and EMA is preferred
- Ability to multitask and take on responsibility in a rapidly moving and cutting edge scientific environment