Clinical Trials Manager

About the role

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Responsibilities

• Coordinating and supervising all aspects of a clinical study.
• Makes sure clinical trial sites are monitored.
• Aids the Clinical Program Manager in overall study management.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of study budget.
• Contributes to development of RFPs and participates in selection of CROs/vendors.
• Manages CROs/vendors.
• Collaborates in reviewing data listings and preparing interim/final clinical study reports.
• Might contribute to the development of abstracts, presentations, and manuscripts.
• Ensures effectiveness of site budget/contract process.
• Might be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
• Assists in determining the activities to support a project’s priorities within functional area.
• Under supervision, might design scientific communications within the company.

Requirements

• Excellent teamwork, communication, decision-making and organizational skills are required.
• Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.

Qualifications

• BS or BA in a relevant scientific discipline and 6 + years of relevant experience OR RN license (2 or 3 year certificate) and 6 + years of relevant experience.
• Experience in the following therapy areas is helpful: Hematology, Oncology, Rheumatology, Autoimmune disorders.
• Familiarity and experience with In-Vivo studies.

Skills

• General, functional expertise to support SOP development and implementation.
• Ability to examine functional issues from an organizational perspective.
• Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.

Benefits

The salary range for this position is: Bay Area: $146,540.00 - $189,640.00. Other US Locations: $133,195.00 - $172,370.00. 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.

For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.