Clinical Program Manager
Clinical Program Manager
Ireland - Dublin
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
The Clinical Operations team in Gilead Dublin is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric 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. He/She 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.
- 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.
- May design and use all available vehicles for scientific communication within company.
- May design scientific communications.
- Travel is required.
Knowledge, Experience & Skills:
- BSc or BA in a relevant scientific discipline or RN qualification.
- At least seven years 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.
- Demonstrates knowledge of how the clinical trial operations impact the broader strategic goals of the Company.
- Ability to work independently with minimal oversight, identify issues and adapt to changes.
- Demonstrates an ability to interact with contacts cross-functionally at senior levels within the Company.
- Ability to examine functional issues from a broader organizational perspective.
- Must have functional expertise to initiate, author, or contribute to SOP development, implementation and training.
- Excellent teamwork, communication, decision-making and organizational skills are required.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of clinical trials.
- Strong communication and influence skills and ability to create a clear sense of direction is necessary.
- Excellent interpersonal skills and demonstrated ability to lead is required.
- Excellent verbal, written and presentation skills are 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.
For Current Gilead Employees and Contractors:
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