Celgeneis a global biopharmaceutical company leading the way in medical innovation tohelp patients live longer, better lives. Our purpose as a company is todiscover and develop therapies that will change the course of humanhealth. We value our passion for patients, quest for innovation, spiritof independence and love of challenge. With a presence in more than 70countries - and growing - we look for talented people to grow our business,advance our science and contribute to our unique culture.
The Clinical Research Scientist, Translational Development, leads the tactical support efforts of Early Development clinical trials from a clinical science perspective. This function works in collaboration with the Medical Monitor responsible for clinical trial oversight in hematology and oncology indications to effectively lead and implement Translational Development compound strategy. This function is accountable for working closely with the project and study teams to deliver enhanced efficiencies and quality around tactical deliverables, including IND and other regulatory submissions, protocol development, amendments and other supporting clinical documents (eg. case report forms), PK/PD and clinical data collection and analysis, investigator and site communications, study reports and publications.
Responsibilities include, but are not limited to, the following:
•Represent Translational Development in cross functional teams/meetings (e.g. Project Teams, Study Sub-teams, Safety Review Committees and Management Teams, etc.).
•Collaborate with project and functional teams in Translational Development on compound strategy and tactics and development of Translational Development Product Development Plans.
•Support cross-functional sub-team meetings in collaboration with the Medical Monitor.
•Author, develop, and amend clinical study protocols, consent forms, case report forms and ancillary documents in collaboration with the Medical Monitor and study teams.
•Oversee the preparation of a clinical development research plan (CDRP) that outlines the seminal summary data tables, figures, listings and patient profiles to monitor company-sponsored studies in collaboration with data management and clinical programming.
•Work with Clinical Operations and Data Management in database review, query and clean-up activities in real-time and prior to database lock.
•Work with the Medical Monitor and translational scientists in data preparation and review for Safety Review Committee meetings, Early Development Advisory Committee (EDAC) Candidate Development Committee (CDC) meetings, Quarterly Review meetings and various other internal and external meetings.
•Work with the Medical Monitor and translational scientists in preparation of abstracts, posters, oral presentations and manuscripts on Early Development trials and compounds.
•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
Bachelor’s Degree required. Advanced degree(s) in relevant field: RN/PharmD/PhDwith experience in hematology/oncology disease indications, preferred.Extensive academic/industry experience including 7 or more years relevantexperience in clinical/translational research working on IND and other regulatory submissions, phase 1to Proof-of-Concept protocol development, PK/PD, safety and clinical datacollection and analysis, investigator and site communications, study reportsand publications.
Skills/Knowledge Required: •Bachelor’s degree required; RN/PhD/PharmD preferred. •Minimal 5 years pharmaceutical/biotech industry or related experience; minimal 7 years experience for senior or principal CRS. •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.
Celgene iscommitted to equal opportunity in the terms and conditions of employment forall employees and job applicants without regard to race, color, religion, sex,sexual orientation, age, gender identity or gender expression, national origin,disability or veteran status.
Celgene complieswith all applicable national, state and local laws governing nondiscriminationin employment as well as employment eligibility verification requirements ofthe Immigration and Nationality Act. All applicants must have authorization towork for Celgene in the U.S.