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.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening
diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.
Kite, a Gilead Company, is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day discoveries that include our own capabilities and our individual potential.
The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.
An exciting and challenging opportunity has arisen to join the European Headquarters based in Stockley Park, Uxbridge as a Senior Clinical Trial Manager.
Essential Duties and Job Functions:
Manages component of global outsourced studies managed by a Clinical Program Manager.
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 participate in selection of CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• Ensures effectiveness of site budget/contract process.
May 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.
Partners with Clinical Program Managers and Managers in other functions, providing input
where key decisions impacting business operations will be made.
Specific Responsibilities:
Works with Clinical Program Managers to manage processes of clinical trial and with latitude for independent judgment and decision-making within defined guidelines.
Demonstrated success in managing members of the team and supporting their
professional development.
• Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity by managing through others or delegation.
Understands how the design and operations of clinical trials impact the goals of various
functions.
In partnership with CPMs, provides guidance and daily oversight for the successful
management of all aspects of international clinical trials within designated program budgets
and timelines.
• Contributes to development of abstracts, presentations and manuscripts.
Basic Requirements:
Preferred Requirements:
• Educated to degree level or above within a scientific discipline
• Oncology experience is essential
• Previous study management experience at trial management level
• Previous monitoring experience is desired but not essential for the role
• Line management is desired but not essential
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and
• GCPs governing the conduct of clinical trials is desirable -experience, interpreting, and explaining protocol requirements to others
•Excellent functional expertise to support SOP development and implementation
• Excellent teamwork, decision-making, communication and organizational skills
Gilead & Kite Core Values
• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity)
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.
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.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.