Senior Director, Clinical Application & Data Services

The Senior Director of Clinical Applications and Data Services is a leadership role accountable for the development, oversight, and change management of innovative solutions and technology services to support Clinical Operations. The role will provide direct oversight in the design and development of customized applications as well as implementation of commercialized products (SaaS) to meet emerging needs within clinical trial execution and site operations. Although, the position requires a strong knowledge of specific programming languages and software development, the position will also strategically focus on adoption and transition to industry proven scalable cloud-based platforms and applications. An important part of the role will be to establish integrations and be accountable for the data quality and integrity within the responsible systems. As a manager of direct staff reports, the leader will provide guidance, coaching, project prioritization, and participate in goal performance discussions.

Core Responsibilities:

• Partner with the Executive Director of Development Clinical Systems and Senior Leadership to build future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IS enterprise strategy and cost of ownership.
  
• Provide technical leadership and accountability for the development, maintenance, and quality oversight of legacy custom applications used to support a variety of clinical operation processes, including safety documentation, resource tracking & forecasting, and study risk management.
  
• Establish strong partnerships and perform due diligence with external providers/vendors to ensure all service level agreements are achieved, optimized transactional and system performance is maintained, and align to industry data and security handling regulations and practices.
  
• Act within an inspection-ready and quality mindset across all activities and represent as needed during internal and external audits.
  
• Be a change advocate, by stewarding and pioneering transformational tasks and activities which focus on automation, simplification of processes and system design, and seeking methods to ensure strong interoperability amongst the larger clinical ecosystem.
  
• Collaborate with data sciences and analytical teams to support the standardization of data assets and create methods to aggregate various data streams to support trend and portfolio/Therapeutic Area/Program level analysis.
  
• Modernize processes by leveraging AI/ML/NLP and RPA techniques and methods to replace manual activities and tasks.
  
• Build strong relationships with cross-functional peers (i.e. Clinical Operations, Digital Health, IT, etc…) to create innovative solutions which accelerate clinical trial development.
  
• Lead staff with a clear sense of purpose, direction, and prioritize the importance of staff growth, aligning opportunities with desired skillsets.
  

Education & Qualifications:

• Bachelor's degree with 16+ years or Master's degree with 14+ years of relevant systems/process/operations experience in the pharmaceutical industry.
  
• Deep understanding of relational database structures and maturity in programming languages (e.g. C#, .Net, Java and integration tools (MuleSoft, Pipeline pilot)) with the goal of maintaining existing applications and next generation systems.
  
• Proven track record in leading cross-functional teams to deliver high-fidelity user-experience systems, which directly achieve business requirements and top-quality standards.
  
• Experience and proven resilience to solve complex technology problems and lead error troubleshooting activities with IT and external vendors.
  
• Demonstrated excellence in forging and maintaining collaborative, positive and long-lasting partnerships with system stakeholders: functional leaders, end-system user communities, IT, external partners
  
• Successful at negotiating and influencing stakeholders with respect to project scope, technology selections, and timelines.
  
• Proven ability to think critically and creatively address long-range goals and objectives.
  
• Strong knowledge in GxP, ICH, and international regulations to ensure systems are developed and maintained according to proper documentation, security protocols, account management, and validation standards.
  
• Extensive experience with data transfers (APIs, ETLs, web-services, etc…) to help develop a well-configured interoperable clinical data ecosystem.
  
• Strong understanding of clinical trial development and associated processes to ensure technology designs and future roadmap align to support clinical operations and clinical result requirements.
  
• Applied understanding of computer system testing, including validation methodology, development, and execution.
  
• Experience in managing staff through the development of performance goals, building top talented teams notable for delivering multidisciplinary projects, and enriching staff through coaching and mentoring.
  

For Colorado Job Applicants: The salary range for this position is:
$191,760.00 - $287,640.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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