Clinical Research Scientist

Job Description

Req #: 1903703
Location: San Francisco, California, United States
Job Category: Medical
Work Location: 1500 Owens Street 94158
Organization: Clinical Research Scientist
Employee Status: Full-time
Job Type: Regular

The Clinical Research Scientist, Translational Development, leads the tactical support efforts of Early Development clinical trials from a clinical science perspective. The incumbent works collaboratively with the medical monitor (CRP) responsible for clinical trial oversight in hematology and oncology indications to effectively lead and implement translational development strategy for early clinical stage compounds. This function is accountable for working closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, including IND/CTA and other regulatory submissions, protocol development/ amendments and other supporting clinical trial documents (e.g. case report forms), clinical data quality assurance , investigator and site communications, study reports and publications.
Specific Responsibilities include, but are not limited to, the following:

• In collaboration with the medical monitor (CRP), represent Translational Medicine in cross functional teams/meetings (e.g. global project teams, study teams, safety review committees, etc.).

• Contribute to creation of an early clinical development strategy both pre-development candidate (DC) nomination (in the context of translational team deliberations) and post-DC nomination (in the context of global project team deliberations).

• Contribute to the authorship/review and amendment of clinical study protocols, consent forms, case report forms and other clinical study documents in collaboration with the medical monitor and cross-functional study teams.

• In collaboration with data management/clinical programming counterparts, oversee the preparation of a clinical data review plan (CDRP) that outlines the process and timelines for and contributors to development of clinical data deliverables (e.g. data tables, figures, listings, patient profiles) for Celgene-sponsored early development studies.

• Collaborate with clinical operations (i.e. study manager, CRAs), data management and the medical monitor in the review, querying and reconciliation of clinical data both in real-time and prior to database extraction.

• Assist the medical monitor and translational research scientists in preparation of data summaries for review at Safety Review Committee meetings, Early Development Advisory Committee (EDAC) Candidate Development Committee (CDC) meetings, Quarterly Research Review meetings and various other internal meetings.

• Assist the medical monitor and translational scientist in the preparation of abstracts, posters, oral presentations and manuscripts for the purpose of peer-review and reporting of results from Early Development clinical trials at various external meetings (e.g. ASH, ASCO, EHA, ESMO), with the assistance and support of Celgene Scientific Communications..

• Work with the Medical Monitor and compound leader in preparation for, and organization of, translational development advisory boards.

• Guide the Study Manager, CRAs, and others, in the day-to-day conduct of clinical studies from a clinical science perspective.

• Attend professional meetings and congresses, as relevant, to support and represent early development compounds and development.

• Actively engage/interact with key stakeholders, including: 1) internal: medical monitor, clinical operations, translational scientists, translational development leadership, project leadership, data management and biostatistics, regulatory affairs, medical writing, QC/CQA, clinical pharmacology, preclinical toxicology, CMC; and 2) external: clinical investigators, study coordinators, advisory board participants

Skills/Knowledge Required :

• Bachelor’s degree required; RN/PhD/PharmD preferred.

• Minimal 5 years pharmaceutical/biotech industry or related experience preferred

• Previous experience in Clinical or Translational Development and proficiency in hematology and oncology disease indications required.

• Working knowledge/familiarity with fundamental concepts in cancer biology as they relate to biomarker-driven early stage clinical trials.

• Proficient in clinical trial protocol and CRF development and Clinical Study Report writing.

• Proficient in clinical and scientific data review and analysis. Strong leadership, planning and organization, written and oral communication skills.

• Proficient in industry-standard software (Microsoft Office Suite, electronic data capture, etc.).

• Track record in establishing effective relationships with investigators and study staff.

• Domestic and international travel, as required.

Prerequisites:
Bachelor’s Degree with a concentration in life sciences with 4-7 year related experience required. Advanced degree(s) in relevant field: RN/MSN, MD, PharmD or PhD with experience/knowledge in hematology/oncology disease indications, preferred. One to 4 or more years of academic/industry experience required including (but not limited to): compilation of INDs/CTAs and other regulatory submissions; Phase 1 to proof-of-concept protocol development, study start-up, execution and close-out; basic understanding of clinical pharmacokinetics and/or biomarker development/applications; clinical data collection/review/reconciliation; effective investigator and site communications; and abstract/peer-reviewed publication development.
About Us
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.