Senior Director, Clinical Development – Program Lead Clinical Scientist

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

As part of the Clinical Development Department, the Senior 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 people 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 12+ years of scientific and/or drug development experience

OR

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

OR

Bachelor’s and 14+ years of scientific and/or drug development experience

Preferred Qualifications

• Advanced degree (PharmD, PhD, MS, etc.).
• Experience in the clinical science role, on global phase 2 and 3 studies, and in corporate collaborations.
• Knowledge of hematology/oncology indications of relevance to Kite, especially myeloma, and cellular therapy.
• 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.

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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 to apply for this job.