Gilead Sciences
Associate Director, Clinical Operations (UK/Ireland/Nordics)
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Job Description
POSITION OVERVIEW:
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.
As part of Gilead's Clinical Site Partnership field-based team, you will be responsible for establishing and maintaining relationships with active and potential investigator sites to optimize delivery of clinical trial programs across any of Gilead's therapeutic areas of research, inclusive of site identification and qualification, enrolment planning and execution, timely delivery of database lock and study close out. You will also serve as an effective communication bridge between investigator sites and the Gilead Development organisation and a point of escalation for both Gilead and investigator site staff, including partnering with Gilead and investigator site staff to resolve issues and remove barriers as needed. You will also be responsible for establishing and managing relationships with Gilead’s preferred network of sites within your region.
Additional local responsibilities may be required as needed/appropriate for the local geography.
EXAMPLE RESPONSIBILITIES:
- Establish and maintain strong professional and collaborative relationships with investigator sites by leveraging disease area expertise to optimise delivery of clinical trial programs.
- Develop strategies to drive concierge level support for preferred sites to ensure Gilead becomes the Sponsor of Choice.
- Track key performance metrics to assess site performance and identify opportunities for acceleration and continuous improvement.
- Identify investigator sites in alignment with portfolio strategy and priority to expand Gilead’s clinical research partnership network.
- Maintain therapeutic and technical expertise to enable scientific discussions with the investigator and site personnel.
- Share ongoing information with investigators regarding Gilead's development pipeline and collect and report field-based intelligence in relation to competitive landscape, patient treatment pathways and other operational considerations that may impact Gilead's clinical trial program.
- Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials from study start-up to close-out such as during feasibility, site recommendations, attendance at initiation visits, facilitation of communication and ongoing support of trial enrolment by engaging with site staff to identify enrolment barriers and working with study teams to find solutions.
- Gather constructive feedback and insights from clinical sites to share with Gilead internal stakeholders around clinical studies or programs for improvements.
- Support the development and implementation of applicable site risk plans to ensure achievement of key study and site level milestones such as first patient first visit, delivery of clinical trial enrolment commitments and database lock.
- Serve as a local point of escalation for investigator sites and partner with appropriate parties to resolve issues and remove barriers to clinical trial execution at a site and/or country level.
- Proactively communicate and escalate issues identified at investigator sites and partner with internal functional areas to develop corresponding mitigation strategies and recommended approaches, including participation in development and implementation of solutions to address issues.
- Leverage and present metrics to inform site / country / regional level decision making.
- Develop local knowledge of investigator site capabilities and past performance and provide input into site-level recruitment forecasts, recruitment methodologies, monitor performance and take appropriate action to maintain timelines.
- Partner closely with internal Clinical Operations, Clinical Development, and Medical Affairs to ensure effective communication and unified messaging to investigator sites.
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REQUIREMENTS:
- BA / BS / RN with significant relevant clinical or related experience in life sciences.
- Combination of scientific/medical expertise in a relevant therapeutic area, including knowledge of the clinical research landscape, and advanced knowledge of Clinical Operations (Oncology, Virology and Inflammation experience are a bonus).
- Previous experience in study operations and project management with operational/oversight of clinical studies.
- Strong working knowledge of Good Clinical Practice and UK/EU country regulatory guidelines and requirements.
- Strong self-management and organisational skills; ability to manage workload, set priorities and adjust as needed.
- Ability to work both independently and collaboratively.
- Established relationships and experience in both the community and academic site and network settings.
- Excellent verbal and written communication and oral presentation skills.
- Ability to establish and maintain strong long-term relationships with internal and external key stakeholders.
- Strong interpersonal skills and understanding of team dynamics.
- Strong leadership presence with demonstrated ability to lead without authority at all levels of internal and external stakeholders.
- Strong negotiation and conflict resolution skills.
- Demonstrated strategic agility and broad business acumen.
- Possess a combination of critical thinking and operational expertise and efficiency.
- Self-motivated with proactive issue monitoring and seeks opportunities to remove barriers.
- Regular 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 apply via the Internal Career Opportunities portal in Workday.
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