Director, Clinical Development - Santa Monica, CA, United States - Kite Pharma

Description

For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead.

We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.

We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Job DescriptionAs part of the Clinical Development Department, the Director, ClinicalDevelopment 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, you will provide scientific guidance and support to the team.

You 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.

ResponsibilitiesIntegrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studiesAcquires and utilizes knowledge of clinical trial design and relevant disease indications to assist in study concept and protocol development.

Contributes to discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents.
Contributes significantly to the development of CRFs, edit checks, IVRS specifications, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysisDesigns patient profiles and writes accompanying medical data review rulesLeads data cleaning effort in preparation for dose escalation or DSMB meetings, as applicable to study stageOrganizes and manages external medical advisory committees for the study team such Scientific Steering Committees, as instructed by the medical monitorResearches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, or investigator meeting materialsContributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study dataAddresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs)

Assists in writing or reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documentsSupports priorities within the functional area and contributes to or supports department initiatives as requestedTrains other clinical scientists as neededBasic Qualifications Doctorate and 8+ years of scientific and/or drug development experienceORMaster's and 10+ years of scientific and/or drug development experienceORBachelor's and 12+ years of scientific and/or drug development experienceORHigh School Diploma/GED and 16+ years of scientific and/or drug development experiencePreferred QualificationsAdvanced degree (PharmD, PhD, MS, etc.)Experience in a clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studiesAble to translate technical concepts into accessible language and direction for the broader study teamFlexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictateExperienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as J-Review and Medidata Rave or similarThorough understanding of ICH GCP, as well as general knowledge of industry practices and standardsExcellent interpersonal, organizational, written, and verbal communication skillsAbility to work effectively on teams with a combination of remote and office-based team membersExemplify our core values of integrity, accountability, teamwork, excellence, and inclusion#LI-ML1The salary range for this position is:
$216, $279, Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.


For additional benefits information, visit:

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.

The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.

Kite is based in Santa Monica, CA. For more information on Kite, please visit . Sign up to follow @KitePharma on Twitter at .

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In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job

SummaryLocation:
United States - California - Santa Monica; United States – RemoteType: Full time