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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 Description

As part of the Clinical Development Department, the Director, Clinical Development fills a key role as the Program Lead Clinical Scientist for one of Kite's cellular therapy programs. Working in close collaboration with the VP, Clinical Development (Program Lead Physician), the incumbent will provide scientific guidance and support to the team. He or she will be responsible for overseeing multiple studies within the program and 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. The Program Lead will also have management responsibilities for other clinical science staff on the program.

Responsibilities

• 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 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 analysis.

• Designs patient profiles and writes accompanying medical data review rules.

• 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 as Scientific Steering Committees, as directed by the medical monitor.

• Researches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, or investigator meeting materials.

• Contributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data.

• Addresses 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 documents.

• Supports priorities within the functional area and contributes to or leads department initiatives as requested.

• People management responsibilities for other clinical science staff.

Basic Qualifications

Doctorate and 8+ years of scientific and/or drug development experience

OR

Master’s and 10+ years of scientific and/or drug development experience

OR

Bachelor’s and 12+ years of scientific and/or drug development experience

Preferred Qualifications

• Advanced degree (PharmD, PhD, MS, etc.).

• Experience in the clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studies.

• People management experience.

• 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.

#LI-ML1

The salary range for this position is: $216,070.00 - $279,620.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• 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 www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.