The Clinical Research Scientist, Hematology/Oncology Translational Development TD , leads the tactical efforts for early development clinical trials from a clinical science perspective. The incumbent works collaboratively with the clinical research physician CRP , who is responsible for clinical trial oversight as well as leadership and implementation of the overall development strategy for hematology/oncology, early clinical stage compounds.
The incumbent is accountable for working closely with the global project and study teams to optimize efficiency and quality around tactical deliverables, including IND/CTA and other regulatory submissions, study protocol/amendments and supporting clinical trial documentation eg. informed consent forms, case report forms , clinical data quality assurance, clinical trial site interactions/updates, study reports and peer-reviewed publications.
This position involves participation in up to two studies/programs of varying complexity and requires active engagement with key internal stakeholders, including the CRP, clinical and TD operations personnel, translational research TR scientists, translational development and project/team leadership, and cross-functional counterparts in data management and biostatistics, regulatory affairs, drug safety, medical writing, clinical pharmacology/clinical quality assurance CQA , preclinical toxicology and CMC.
Additionally, the incumbent must be able to effectively engage with key external stakeholders including clinical trial site personnel. This position receives moderate supervision from the TD CRP s .
Specific Responsibilities include, but are not limited to, the following:
In collaboration with the CRP, represents Translational Medicine in cross functional teams e.g. transition teams, global project teams, study teams, safety review committees, etc.
Contributes to the creation of the early clinical development strategy pre-development candidate DC nomination in the context of translation team deliberations) and post-DC nomination (in the context of global project team deliberations)
Contributes to the authorship/review and amendment of clinical study protocols, consent forms, case report forms and other clinical study documents in collaboration with the CRP and cross-functional study team members
In collaboration with data management/clinical programming counterparts, oversees the preparation of a clinical data review plan (CDRP) that outlines the process and timelines for and contributors to the generation of clinical data deliverables (eg. data tables, figures, listings, patient profiles) for Celgene-sponsored early development studies
Coordinates with clinical operations personnel (ie. study managers, CRAs), data management, the CRP and drug safety manager/physician in the review, querying and reconciliation of clinical data both in real-time and prior to database extraction
Assists the CRP and TR scientists in the preparation of data summaries for presentations at Safety Review Committee meetings, Early Development Advisory Committee (EDAC) meetings, Candidate Development Committee (CDC) meetings, Quarterly Research Review meetings and other internal meetings
Collaborates with the CRP and translational scientist in the preparation of abstracts, posters, oral presentations and manuscripts for the purposes of peer-review and reporting of results from Early Development clinical trials at various external meetings (eg. ASH, ASCO, EHA, ESMO), with the assistance and support of Celgene Scientific Communications.
Functions in a technical support role for the study managers, CRAs and study site personnel in the day-to-day conduct of clinical studies
Assists as needed, in preparation of the agenda and meeting contents for TD advisory board and investigator meetings
Attends professional meetings, congresses, and external Celgene-sponsored meetings as relevant that allow opportunities for networking, the promotion of educational advancement or the purpose for which may be to improve/promote clinical development best practices companywide (eg. specific Project Velocity initiatives).
Bachelor¿s degree with a life sciences concentration required; advanced degree (MSN, MD, MS, PharmD or PhD) in a relevant field with experience/knowledge in hematology/oncology disease states preferred.
Two to 4 years (minimally) of academic and/or pharmaceutical/biotech industry, clinical research & development experience.
Working knowledge of/familiarity with malignant hematology and oncology disease states and fundamental concepts of cancer biology is required.
Prior experience in clinical study protocol, informed consent, case report form design and clinical study report writing.
Prior experience in clinical data interpretation, review and reconciliation.
Strong planning and organizational, written and oral communication skills.
Proficient in the use of industry-standard software (eg. Microsoft Office Suite, WebEx, Medidata RAVE; RAVE X, etc).
Established track record of effective interactions with clinical trial site personnel.
Domestic and international travel, as required.
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