Clinical Program Manager

3 weeks ago

Dublin, Dublin City, Ireland Gilead Sciences Ireland UC Full time

Description

Clinical Program Manager, Clinical Operations - Dublin

The Position
The Clinical Operations team in Gilead Dublin is a pivotal function of the Pediatric Centre of Excellence in Dublin and is responsible for the management and execution of Pediatric 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.

The Clinical Program Manager will be a valued member of the Clinical Operations team in Dublin and will work with the Clinical Trial Manager and study teams to manage studies within a program and across all regions, providing a significant role in oversight and management of programs, leading cross-functional teams, driving performance and ensuring consistent execution of delivery.

Key Responsibilities

• Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.

• Provides Clinical Operations therapeutic area leadership.

• Accountable for successful study completion including clinical trial budgets and timelines.

• Leads cross-functional study management teams and should have good influencing skills with study stakeholders.

• Ensures consistent execution of program requirements across studies in a program.

• Manages study resources and responsible for career development and guidance of direct reports.

• Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.

• Communicates project status and issues and ensures project team goals are met.

• Writes study protocols, study reports, sections for investigator brochures and regulatory documents (e.g. IND, NDA, etc.) with little supervision.

• Develops and progresses RFPs and selection and management of CROs/vendors.

• Anticipates moderately complex obstacles and implements solutions to achieve project goals.

• Resolves problems using national and international regulations, guidelines and investigator interaction.

• Contributes to development of abstracts, presentations, and manuscripts.

• Participates in and/or leads departmental or interdepartmental strategic initiatives.

• Travel is required.

Knowledge, Experience & Skills:

• BA in a relevant scientific discipline or RN qualification.

• Relevant clinical trial experience in the pharmaceutical industry.

• Ability to manage and motivate teams and drive performance.

• Ability to develop study team members.

• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.

• Excels in project management and demonstrates ability to manage studies or programs of greater complexity from both a process and strategic perspective.

Gilead Core Values

• Integrity (Doing What's Right)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

• Inclusion (Encouraging Diversity)

About Gilead
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 investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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 Gilead Employees and Contractors:

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