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 Scientist, I&I Gastroenterology TASummit, NJ
The Clinical Research Scientist (CRS) is responsible for contributing scientific insight and expertise in clinical trial design, statistics, pharmacodynamics and pharmacokinetics to support clinical research projects. The CRS is expected to work collaboratively with other study team members including but not limited to Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory, and Project Leadership 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 regulatory submission documents, study protocols and informed consents. This includes writing, reviewing, amending and facilitating cross-functional review as appropriate. Collaborate with Key Opinion Leaders as required.
- Contribute to the Clinical Development Plan (CDP);
- Assist the Clinical Research Physician (CRP) to make recommendations, take action and provide clinical research expertise related to projects;
- Interface collaboratively with study team members, e.g. Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Leadership & Management;
- Along with Celgene Study Team, provide relevant support to CRO in the management of clinical studies.
- Actively participate and contribute to study/project team meetings; may represent CRP at study team meetings when appropriate.
- Review scientific literature related to assigned clinical programs;
- Provide scientific expertise to other departments and line functions;
- Review and interpret study data as it relates to efficacy and safety.
- Provide scientific input, review, and edits to clinical study reports, Investigator Brochures, narratives, INDs, NDAs, briefing documents, annual reports, and other regulatory submissions. May be called to assist in writing these documents.
- Organize and provide training assistance to departments/vendors (scientific/development improvements).
- Serve as a liaison with internal/external scientific and medical experts to ensure protocol execution is consistent with intent. Coordinate and oversee medical or endpoint-specific training for study protocols.
- Assist with planning of, and participate in, Investigator Meetings and Advisory/Scientific boards. Prepare and present clinical data in these venues as needed.
- Assist with budget projections for clinical activities (such as consultants, advisory board meetings, etc.) for assigned clinical programs;
- Prepare DMC and/or adjudication charters. Prepare deliverables and participate in periodic review meetings.
- Provide Clinical Management with regular study updates/status reports.
- Perform other tasks as assigned by supervisor
- 5-7 years of biotech/pharma/CRO experience with at least 3 years in clinical research and development.
- Bachelors degree required with a concentration in life science preferred. Masters degree, PhD or Pharm D. OR EQUIVALENT preferred.
- Previous experience in Gastroenterology is a plus.
- Proven medical/scientific writing skills
- 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
- Demonstrated ability to work as part of a team
- Detail-oriented, well-organized
- Able 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.