Celgene Clinical Research Scientist in San Diego, California

Description

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 Senior Clinical Research Scientist will be expected to take a leadership role in designing the I & I study protocols and overseeing the implementation and conduct of I and I clinical trials to ensure the quality and integrity of data and safe and proper management of line functions’ deliverables, in coordination with clinical operations and clinical study team members. The Senior Clinical Research Scientist will also compile and summarize data for inclusion in clinical study reports, summary documents for global health authority submissions and responses to assessment questions for submitted dossier. Limited travel required as needed to support clinical programs.

Major Responsibilities:

  • Design and develop study protocols and informed consents. Generate/review of other related study documents such as IB, FDA briefing documents and forms (e.g. unique project specific CRFs, diaries, etc.), as needed

  • Provides scientific expertise to other departments and line functions

  • Interface with project team members, e.g. Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management

  • Assist the Clinical Research Physician (CRP) to make recommendations, take action and provide clinical research expertise related to projects

  • Assist in writing and providing scientific input, review, and edits of clinical study reports, Investigator Brochures, INDs, NDA annual reports, integrated medical reports, and other regulatory submissions

  • Review scientific literature related to assigned programs

  • Contribute to the Clinical Development Plan (CDP) and protocols for assigned compounds

  • Assist with review of ongoing summary data including: safety, primary efficacy variables, laboratory data, etc.

  • May lead clinical development team

  • Actively participates and contributes to study/project team meetings; may represent CRP at study team meetings

  • Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or end-point specific training for study protocols

  • Organizes and provides training assistance to departments/vendors (scientific/development improvements)

  • Prepare DMC and/or adjudication charters. Prepare deliverables for periodic review meetings and participate, e.g. Study Management Team

  • Participate in and assist with advisory/scientific boards. Prepare and present clinical data at external scientific/board meetings as needed

  • Provides Clinical Management with regular study updates/status reports on study data

  • Assist with budget projections for clinical activities (such as consultants, advisory board meetings, etc.) for assigned clinical programs

  • Perform other tasks as assigned by supervisor

Knowledge, Skills and Abilities Required:

  • Minimum -2-3 years experience with medical or technical writing

  • Extensive medical/scientific and clinical research knowledge

  • Advanced analytical and influencing skills

  • Knowledge of early and late phase clinical program development

  • Proficient at data interpretation

  • Expert understanding of global clinical study design and drug development processes Knowledge of GCP and ICH Guidelines

  • Experienced in presenting at Investigator Meetings

  • Detail-oriented, well-organized

  • Ability to multi-task

  • Able to work independently; exercise sound judgment, and escalate issues when necessary

  • Ability to assimilate technical information quickly

  • Proficient in Microsoft Word, Excel, PowerPoint; proficiency in Microsoft Project, Visio, and electronic document repository system a plus

  • Demonstrated ability to work as part of a team

  • High level of interpersonal and communication skills (written and verbal)

#LI-POST

Celgene 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.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.