Oncology Cross Functional Area Intern

Description

Oncology Cross Functional Area Intern 2024 Summer Intern (Oncology TA) - (Undergraduate/Graduate)

Job Description

As a summer intern in the Cross-Functional Area role, you will be a member of a clinical team dedicated to the research and development of oncologic therapeutics including, execution of clinical strategies; the clinical and operational implementation of complex compound programs in Phase I to III clinical oncology studies. The selected candidates will be assigned a mentor and will have the opportunity to contribute to clinical trials in our prostate cancer, solid tumors, and hematologic malignancies teams. This role involves extensive global team matrix interactions with colleagues from several different disciplines. 

The Oncology Cross-Functional Area Intern may contribute to Cross-Functional Trial Team (CFTT) activities. The intern may also collaborate with other project teams in various functional disciplines in monitoring and or supporting various aspects of clinical trial conduct. Each intern will have their own or group assigned projects and will be expected to present their work to their project teams, the oncology Senior Leadership Team (SLT), and 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 experience in working in a large pharmaceutical R&D setting and to gain basic understanding of the science and process of novel drug development. Students will have the opportunity to learn aspects of cancer disease states, diagnosis, treatments, and the mechanism of action behind the emerging drugs being developed in in conduct of our clinical trials. Students will also receive detailed training on Standard Operating Procedures (SOPs) as part of the Cross-Functional Area Intern curriculum, trial specific training, and the clinical database software and medical data review tool. 

Overall Responsibilities may include

• Gaining overall understanding of clinical research and drug development including but not limited to Good Clinical Practices (GCPs), International Conference of Harmony (ICH) guidelines, and Standard Operating Procedures (SOPs)
• Participating in department and cross-functional team meetings
• Shadowing key functional roles for learning/development opportunities
• Collaboration and or assigned projects from other various functional areas
• Leadership opportunities on specific program and or group projects
• Abstract/poster preparation and presentation at organization-wide research symposium
• Other projects as assigned

Cross-Functional Area Interns may be assigned to a specific functional area including but not limited to, Clinical Pharmacology, Diversity Equity and Inclusion in Clinical Trials (DEICT), Global Medical Safety, and Portfolio Delivery and Operations. Additional responsibilities for each functional area may include the following:

Clinical Pharmacology:

• Support pharmacokinetics, pharmacodynamics and immunogenicity assessments, data analysis and reporting of clinical results
• Contribute to benefit/risk assessments of how the body is interacting with the drug
• Support determination how the drug will affect special populations, such as children, elderly or those patients with other medical conditions (e.g., renal and hepatic impairment)
• Contribute to optimizing drug dosing regimen to ensure both safety and efficacy and make dosing recommendations.

Diversity, Equity, and Inclusion in Clinical Trials (DEICT):

• Support development, authoring, finalization, and distribution of DEICT content and communications.
• Participate in DEICT Oncology team meetings and facilitate/assist with Oncology Therapeutic Area study team and governance meetings including cross-functional leaders and teams.
• Contribute to DEICT Oncology deliverables and metrics tracking.
• Contribute to socialization of the DEICT dashboard and other tools to track progress of diversity plan implementation.
• Identify and develop process improvements to increase recruitment, enrollment, and retention of clinical trial participants from diverse backgrounds.

Global Medical Safety

• Engagement in routine safety surveillance activities for clinical trial and post marketed data.
• Assist with preparation for Periodic Safety Review (PSR) and Signal Management Team (SMT) meetings via thorough data review of cumulative and interval data review.
• Contributions to efforts supporting an upcoming global submission.
• Supporting Clinical Team with study start up activities during trial set up, and other study tasks during conduct, and closeout.

Portfolio Delivery & Operations

• Support development strategy, study design and protocols for clinical trials that support regulatory submissions and product labeling.
• Engage in clinical trial execution and delivery of oncology studies from start-up to close-out.
• Assist with enrollment and study tracking and ensure study milestones are on track.
• Ensure documents are filed appropriately in vTMF according to filing plan.
• Prepare and review data metrics reports.
• Assist in preparation of data reports for submission.

Qualifications

Qualifications

• Legally/permanently authorized to work in the US with no required sponsorship.
• 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.
• Currently enrolled in a biology, chemistry, clinical pharmacology/pharmacodynamics, pre-med, health sciences, public health, physician assistant, or nursing program or studies in Diversity, Equity, and Inclusion (DEI) or Health Equity/Disparities or similar areas.
• Graduate students must be pursuing a master’s degree (Health Sciences, Public Health), PharmD or PhD degree.
• Must have a minimum cumulative GPA of 3.0 which is reflective of all college coursework.
• Self-motivated and 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 and written communication 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 key Microsoft suite of business tools including but not limited to Outlook, Excel, PowerPoint, Word, Teams, Slack, SharePoint, OneNote, etc.
• Working knowledge and or experience using key Microsoft suite of business tools including but not limited to Outlook, Excel, PowerPoint, Word, Teams, Slack, SharePoint, OneNote, etc.