Clinical Development Scientist

Описание вакансии

As part of the Clinical Development Department, the Clinical Development Scientist fills a key role (Clinical Scientist) on the clinical study team within one of Kite's cellular therapy programs. Working in close collaboration with the study medical monitor, the incumbent will provide scientific guidance and support to the team. He or she will be responsible for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.

Essential Duties and Job Functions:

• Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies
• Acquires and utilizes knowledge of clinical trial design and relevant disease indications to assist with protocol development. Participates in discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents
• Contributes to the development of CRFs, edit checks, IVRS specifications, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis
• Designs patient profiles and writes accompanying medical data review rules as directed by the medical monitor
• Leads data cleaning effort in preparation for dose escalation or DSMB meetings, as applicable to study stage
• Organizes and manages external medical advisory committees for the study team such Scientific Steering Committees, as directed by the medical monitor
• Researches and summarizes scientific or technical information available in published literature for continual self-learning and to assist in preparing training, study manual, or investigator meeting materials
• Participates in the review of statistical analysis plans, table, listing, figure design and presentations of study data
• Addresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs)
• Assists in reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents
• Supports priorities within the functional area and contributes to department initiatives as requested

BASIC QUALIFICATIONS:

• BS/BA in biomedical field and 8 + years relevant scientific and/or drug development experience -OR-
• MS in biomedical field and 6+ years relevant scientific and/or drug development experience -OR-
• PhD or PharmD and 0+ years relevant scientific and/or drug development experience

PREFERRED QUALIFICATIONS:

• Advanced degree (PharmD, PhD, MS, etc.).
• Ideally the candidate will have experience directly in the clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studies
• Able to translate technical concepts into accessible language and direction for the broader study team
• Flexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictate
• Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as J-Review and Medidata Rave or similar
• Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards
• Excellent interpersonal, organizational, written, and verbal communication skills
• Ability to work effectively on teams with a combination of remote and office-based team members
• Exemplify our core values of integrity, accountability, teamwork, excellence, and inclusion