Director, Clinical Development
2 weeks ago
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 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.
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.
The salary range for this position is: $216, $279, Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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 atFor jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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