Clinical Trial Manager (CTM)

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible together.

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 Gileads 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 Stockley Park Uxbridge 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 II-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 projects 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 is required (up to approximately 20%)

Gilead/Kite Core Values

INTEGRITY Doing Whats Right

INCLUSION Encouraging Diversity

TEAMWORK Working Together

EXCELLENCE Being Your Best

ACCOUNTABILITY Taking Personal Responsibility

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 individuals 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 Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.