Associate Director Site Contracts, Clinical Operations
Full Time
Dublin, County Dublin
Posted
Job description
For Current Gilead Employees and Contractors:
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Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.
We are currently seeking an industry leader for an Associate Director, Site Contracts, Clinical Operations role. The key leadership role is responsible for the strategy, planning, oversight, and delivery of EMEA Clinical Site Contracts (Investigator Contracts) and function across the clinical drug development cycle. The successful candidate will have deep expertise in global program design, people management and development, direct vendor oversight the management of Functional Service Providers (FSPs) involved in the contracting process, and project management skills in the biotech or pharmaceutical industries. A strong foundation in operations, site contract lifecycle including payments, pricing (FMV) and project management with the ability to resolve complex issues associated with domestic (US) and international (rest of world) site contracts with support from Gilead Clinical Legal department is critical for success in this role. Ideal candidate will have demonstrated success in working in a matrix environment and collaboratively with stakeholders.
This position will be located at Gilead’s Ireland Ltd. location in Dublin, Ireland.
The core responsibilities and skills required for this position include but is not limited to:
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Leads a team of site contracts professionals globally, and develops others by identifying and mentoring high performers through a culture of inclusion and collaboration
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Exhibits strong managerial skills and demonstrated success in managing multiple direct reports in a global and virtual environmentLeads or manages a functional team within Clinical Operations department
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Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes
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Demonstrates understanding of regulatory and legal issues pertinent to clinical development (Contracts)
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Provides input to strategy for and supports the implantation of Site Contracts strategy and the activities necessary for the development and execution of site contract for Gilead studies.
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Focuses on site contracting, fair market value (FMV) compliance of site contracts, and financial accountability as it relates to FSP management
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Leads the escalations related to the site contracting and budget negotiations in terms of risk management, leading issue resolution at the operational and senior executive levels
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Trains staff in contract budgeting, development, and administration
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Develops appropriate job aides and tracking tools
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Manages contract activities for multiple clinical development programs, ensuring that there is adequate staff with the skills to complete contracts accurately, consistently, and in a timely manner
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Demonstrates a basic understanding of the regulatory implications of contracts as related to clinical research – Good Clinical Practices (GCPs)
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Utilizes prior experience in the development of, or reporting on, portfolio level Key Performance Indicators, and subsequently uses these to drive performance goals and improvements, as necessary
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Delivers with optimal collaboration, accountability, and integrity to business partners
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Shows the clear ability to apply critical thinking, strategy development, and vision towards the growth of the vendor relationship management program, while also overseeing the day-to-day execution in a high volume, fast paced environment.
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Participates in establishing departmental and cross-functional policies and procedures.
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Translates the usage of industry best practices to the overall program, utilizing external sources such as benchmarking, data, and processes to continually provide input and drive improvements linked to an overall strategy.
Required Experience:
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Significant years of experience with a BA in a relevant discipline
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Several years of experience with a MS in a relevant discipline
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Relevant years of experience managing a team of 3 or more
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Global Clinical Site Contracts Experience within Industry
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MBA or JD Preferred.
Knowledge & Other Requirements:
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Competent in computer skills (Microsoft Office including Excel, Word and PowerPoint)
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Development of End User Documentation Tools a plus
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Skilled at development and delivering staff training
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Relevant experience typically includes site contracts, site budget development and negotiation (FMV), clinical site payments process improvement, and program development
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Familiarity with operational tools such as six-sigma, lean, and process mapping a plus
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Advanced certification (PMP, etc.) a plus
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Some Travel required.
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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:
Please log onto your
Internal Career Site
to apply for this job.
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