Job Description

We offer an inclusive work culture that is open, innovative, and performance driven. As a s ummer i ntern in the Clinica l Scientist role, you will be a member of a clinical team dedicated to the research and development (R&D) of on cologic or immunologic therapeutics. S elected candidates will be assigned a mentor and will have the opportunity to contribute to clinical trials. This role involves extensive global team matrix interactions with colleagues from several different disciplines and may provide exposure to the execution of clinical strategies and the clinical and operational implementation of complex compound programs in Phase I to III clinical oncology or immunology studies.

The Clinical Scientist intern may contribute to Cross-Functional Trial Team (CFTT) activities, including but not limited to developing the clinical trial protocol, clinical trial materials, literature searches and review, medical review of trial data, coordinating the completion of clinical study reports and provid ing support (as needed) for preparation of relevant documents for regulatory filings. The intern may also collaborate with the Study Responsible Scientist (SRS), the Study Responsible Physician (SRP), and or other project team member s in various functional disciplines in monitoring and/ or supporting various aspects of clinical trial conduct. Each intern will have one primary research project and may have additional assigned projects as determined by the mentor and team. Interns will be expected to present their work to their project teams, the O ncology or Immunology S enior L eadership Team (SLT), and are required to present their primary research project as a poster/abstract at the research symposium at the end of the internship.

The goal of this internship program is to provide undergraduate and graduate students with experience in working in a large pharmaceutical R&D setting and to gain a basic understanding of the science and process of novel drug development. Students will have the opportunity to learn aspects of cancer or immunological disease state s, diagnosis, treatment s, and the mechanism of action behind the emerging drugs being developed in our clinical trials. Students will also receive training on Standard Operating Procedures (SOPs) as part of the Clinical Scientist Intern curriculum, trial specific training, and the clinical database software and medical data review tool.

Responsibilities may include:

• Gain ing an overall understanding of clinical research and drug development including but not limited to Good Clinical Practices (GCPs), International Conference of Harmony (ICH) guidelines, and St andard Operating Procedures (SOPs)
• Assist ing with the management of trial activities including patient tracking through the screening process, and eligibility/ enrollment reviews
• Assisting with document processing and management within the electronic master file (i.e., vTMF)
• Participating in department and team meetings
• Participating in cross-functional team and clinical team meetings
• Develop ing study training materials/documents
• Shadow ing key clinical and or functional roles for learning/development opportunities
• Observ ing Site Initiation Visit (SIV) Meetings
• Support ing Clinical Team with study start-up activities during the trial set up, and other study tasks during conduct, and close out.
• Assist ing with the review and cleaning of clinical data (i.e., medical review), query generation, and resolution.
• Assist ing with interpretation, report ing, and prepar ation of oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions.
• Review ing medical literature, related products, and new technologies.
• Providing necessary training to the local operational teams.
• Collaboration and/ or assigned projects from other various functional disciplines.
• Leadership opportunities on specific program and/ or group projects.
• Abstract/ p oster preparation and presentation at an organization-wide research symposium

• Legally/permanently authorized to work in the US with no required sponsorships
• Must be currently enrolled in an accredited University or College program throughout the duration of the internship.
• Undergraduate college students with completion of a minimum of four semesters and with some lab experience
• Student in good standing, working towards the completion of an undergraduate or graduate degrees
• Must have experience or pursuing a degree in biology, cell/molecular biology, biochemistry, genetics, immunology/immuno-oncology, computational biology, or similar areas of study
• Graduate students must be pursuing a master’s or a PhD degree
• Self-motivated, future scientist leaders passionate about drug development and clinical research
• Proven leadership/participation with campus programs and/or service programs is desired
• Detailed oriented with good organizational skills
• Possess strong leadership skills to participate and contribute to program initiatives and events
• Fluent in written and spoken English
• Great interpersonal, verbal, written communication and presentation skills
• Good presentation skills; leading presentations to peers, project teams and senior leadership teams
• Enthusiastic, collaborative, able to build relationships and work within global matrixed and cross-functional teams
• Ability to work on and balance multiple project deliverables
• Working knowledge and/or experience using Microsoft suite of business tools including but not limited to Outlook, Excel, and PowerPoint, Word, Teams, Slack, Sharepoint, OneNote, Etc.

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