Job Title
Clinical Trial Manager – Cell Therapy – European Headquarters (UK)
The Position
Opens an opportunity to join Gilead’s Clinical Operations team in headquarters based in the UK. Responsibilities include managing the European component of global or local Cell Therapy studies and leading cross‑functional collaboration across clinical and regulatory functions.
Essential Duties and Job Functions
- Manages the European component of global Phase I–III outsourced studies.
- Drafts and coordinates the review of relevant documents: protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
- Maintains study timelines.
- Contributes to study budget development.
- Contributes to RFP development and participates 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 activities that support a project’s priorities within the 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, can 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 trials or entire local trials, identifying issues and adapting to change.
- Interacts with cross‑functional teams internally and externally to ensure trial progress.
- Incorporates study logistics and planning to accomplish study objectives.
- Serves 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 of FDA and EU regulations, ICH Guidelines, and GCP governing 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 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.
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.
