Clinical Research Scientist
Other Locations:US- NJ- Summit East
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.Clinical Research ScientistSummit, NJ
The Clinical Research Scientist, Inflammation & Immunology is responsible for contributing scientific insight and expertise in clinical trial design, statistics, pharmacodynamics and pharmacokinetics to support ongoing clinical research projects. Interface with project team members including Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management, in order to develop and implement regulatory strategies and preparation of material for regulatory authorities and management.. Limited travel required as needed to support clinical programs.
Responsibilities will include, but are not limited to, the following:
- Prepare key documents for Investigator Brochures (“IB”), regulatory submission documents, internal/external presentations, and related documents to support clinical research and drug development for Inflammation & Immunology therapeutics.
- Prepare protocols and guidelines, including writing, reviewing, amending and cross-functional facilitation as appropriate, and collaborating with Key Opinion Leaders as required.
- Prepare and review clinical study reports in order to determine potential drug indicators and clinical development plans.
- Prepare summary documents based on review of scientific literature for inclusion in IB, protocols, and regulatory submission documents.
- Plan and develop assigned compounds and assisting with development of CDPs. Oversee and challenge the adequacy of planning for study implementation.
- Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals.
- Provide clinical research expertise in the guidance and recommendations to Clinical Research Physicians in the management of ongoing projects.
- Prioritize project/study timelines to ensure adequate staffing for data management, drug supply, clinical operations, and drug safety.
- Collaborate and support operational objectives as needed. Assist in establishing project budgets and Standard Operating Procedures, and reviewing ongoing study data including: safety, primary efficacy variables, and laboratory data.
- Plan, participate and present at investigator meetings and ad-hoc meetings.
- 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
- 1-6 years of biotech/pharma/CRO experience with at least 1-3 years in clinical research and development.
- Degree in Life Sciences (e.g. BS in Nursing, Pharmacy or related medical field), Masters degree, PhD or Pharm D. OR Equivalent preferred.
- Previous experience in inflammation and immunology a plus.
- Minimum -1-3 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
#LI-POSTCelgene 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.