Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Sr. 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 (e.g. 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 a minimum of 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, TD 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 minimal to moderate supervision from the TD CRP(s). Mentoring of level II (CRS) personnel may be part of the Sr. CRS role under certain circumstances.
Specific Responsibilities include, but are not limited to, the following:
BIO-USCelgene is committed to equal opportunity in the terms and conditions of employment for all 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 complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.