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Description
About Celgene
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 60 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology and hematology. If you’d like to join a company where you can make a difference, please consider the Celgene family.
Prerequisites
• Completed BA/BS or MA/MS degree in life sciences (e.g., Nursing, Pharmacy or directly-related field) required;
• Require 4 or more years of professional experience in clinical research development (or directly-related experience); and
• Require 2 or more years of professional experience in medical or technical writing; and
• Excellent written and verbal communication and interpersonal skills required. The Clinical Research Scientist (CRS) must be able to relate effectively to people at all levels of the organization.
Summary
The Clinical Research Scientist assists the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
Responsibilities will include, but are not limited to, the following:
1. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
2. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Collaborate with Key Opinion Leaders as required.
3. Clinical study report preparation/review.
4. Review literature and prepare summary documents for inclusion in IB, protocols, regulatory submission documents, etc.
5. Participate in Development Planning for assigned compounds and assist with development of CDPs.
6. Oversee and challenge the adequacy of planning for study implementation.
7. In collaboration with the project physician, direct the planning and implementation of clinical programs to meet corporate and clinical research goals.
8. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects.
9. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g., data management, drug supply, clinical operations, and drug safety).
10. Collaborates and supports operational objectives as needed.
11. Assist in establishing project budgets.
12. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
13. Participate and present at investigator meetings.
14. Participate in ad-hoc meetings (e.g., marketing).
15. Assist in document template design and SOP writing.
16. Participate on various corporate committees.
17. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required.
18. Lead team meetings as required.
Skills/Knowledge Required:
• BA/BS or MA/MS degree in life sciences (e.g., Nursing, Pharmacy or directly-related field) required.
• Require 4 or more years of professional experience in clinical research development (or directly-related experience)
• Require 2 or more years of professional experience in medical or technical writing.
• Excellent written and verbal communication and interpersonal skills required. The Clinical Research Scientist (CRS) must be able to relate effectively to people at all levels of the organization.
• Extensive medical/scientific and clinical research knowledge required.
• The CRS must have knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics.
• Proficiency at data interpretation required.
• Experience in protocol development, study report preparation, Investigator Brochure preparation, and regulatory submissions required.
• Must have experience in all aspects of the drug development process.
• Knowledge of GCP and ICH Guidelines required.
• Experience in presenting at Investigator Meetings required.
• Must be detail-oriented and well-organized.
• Limited overnight business travel may be required.
• Ability to assimilate technical and scientific information quickly required.
• Clinical project management skills required.
• Must be proficient in Microsoft Word, Excel and PowerPoint.
• Demonstrated ability to work as part of a team required.
Preferred Skills/Knowledge:
• Experience in designing early drug development protocols a plus.
• Experience in immunology and inflammatory diseases (e.g., dermatology, renal and/or respiratory indications) a plus.
• Knowledge of experimental biology (e.g., biomarkers) and pathophysiology a plus.
• Clinical monitoring experience is a plus.
• Working knowledge of Microsoft Project and Visio a plus.
Equal Employment Opportunity
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.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the at-will employment relationship between the employee and Celgene.
Details:
Job Id:
19245198
Posted / Updated:
5/12/2010 3:57:50 PM
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