Job Information
Gilead Sciences, Inc. Clinical Trials Manager in Uxbridge, United Kingdom
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.
Job Description
The Position
Careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Kite and Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.
An exciting and challenging opportunity has arisen to join the European Headquarters based in UK as a Clinical Trial Manager to be responsible for the management of European and/or global activities on assigned study(ies) within the Cell Therapy Area.
Essential Duties and Job Functions:
Manages European component of global Phases I-III outsourced studies.
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.
Manages CROs/vendors.
Coordinates review of data listings and preparation of interim/final clinical study reports.
May contribute to development of abstracts, presentations, and manuscripts,
Ensures effectiveness of site budget/contract process.
May be asked to train CROs, vendors, investigators, and study coordinators on study requirements and cell therapy logistics.
Conducts oversight monitoring visits as required.
Assists in determining the activities to support a project’s priorities within functional area.
Coordinates and supervises all aspects of a clinical study.
Under supervision, may design scientific communications within the company.
Contributes to Clinical Operations Europe team activities & initiatives
May serve as a resource for others within the company for clinical trials management expertise.
Under general supervision, is able to examine functional issues from an organizational perspective.
Specific Responsibilities:
Works with Clinical Program Managers and Global Clinical Trial Leads to manage the European component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes. There might also be scope for global trial management.
Interacts with cross-functional teams internally and externally to ensure trial progress.
Will incorporate study logistics and planning to accomplish study objectives.
Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Essential Functions:
Oncology/Cell Therapy experience is highly preferable.
Must have multinational (preferably EU) clinical trials experience including study management/coordination.
Monitoring experience highly desirable as site oversight monitoring visits will be required.
Thorough knowledge and understanding of FDA and EU 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.
Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
Must have a general, functional expertise to support SOP development and implementation.
Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
Excellent teamwork, communication, decision-making and organizational skills are required.
International travel may be required.
Gilead/Kite Core Values
INTEGRITY – Doing What’s Right
INCLUSION – Encouraging Diversity
TEAMWORK – Working Together
EXCELLENCE – Being Your Best
ACCOUNTABILITY – Taking Personal Responsibility
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 .
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
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.