Senior Clinical Trial Manager

Senior Clinical Trial Manager

United Kingdom - Uxbridge Clinical Development & Clinical Operations Regular

Job Description

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've 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 world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's 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 we're 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

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.

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:

1. Manages component of global outsourced studies managed by a Clinical Program Manager.
2. Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
3. Maintains study timelines.
4. Contributes to development of study budget.
5. Contributes to development of RFPs and participate in selection of CROs/vendors.
6. Coordinates review of data listings and preparation of interim/final clinical study reports.
7. Ensures effectiveness of site budget/contract process.
8. May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
9. Assists in determining the activities to support a project's priorities within functional area.
10. Partners with Clinical Program Managers and Managers in other functions, providing input where key decisions impacting business operations will be made.

Specific Responsibilities:

1. Works with Clinical Program Managers to manage processes of clinical trial and with latitude for independent judgment and decision-making within defined guidelines.
2. Demonstrated success in managing members of the team and supporting their professional development.
3. Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity by managing through others or delegation.
4. Understands how the design and operations of clinical trials impact the goals of various functions.
5. 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.
6. Contributes to development of abstracts, presentations and manuscripts.

Experience, knowledge and skills:

1. Educated to degree level or above within a scientific discipline.
2. Oncology experience is essential.
3. Must have previous study management experience at trial management level.
4. Previous monitoring experience is desired but not essential for the role.
5. Line management is desired but not essential.
6. Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
7. Must be able to generally understand, interpret, and explain protocol requirements to others.
8. Must have a general, functional expertise to support SOP development and implementation.
9. Excellent teamwork, decision-making, communication and organisational skills.

Gilead & Kite Core Values

1. Integrity (always doing the right thing)
2. Teamwork (collaborating in good faith)
3. Excellence (working at a high level of commitment and capability)
4. Accountability (taking personal responsibility)
5. Inclusion (encouraging diversity)

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.