Senior Director, Clinical Application & Data Services
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: June 18, 2022
Job Description:
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 - $287,640.00Gilead
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 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 for assistance.Following
extensive monitoring, research, consideration of business
implications and advice from internal and external experts, Gilead
has made the decision to require all U.S. employees and contractors
to receive the COVID-19 vaccines as a condition of employment.
"Full vaccination" is defined as two weeks after both doses of a
two-dose vaccine or two weeks since a single-dose vaccine has been
administered. Anyone unable to be vaccinated, either because of a
sincerely held religious belief or a medical condition or
disability that prevents them from being vaccinated, can request a
reasonable accommodation.---For more information about equal
employment opportunity protections, please view the 'EEO is the
Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS
UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY
NONDISCRIMINATION PROVISION Our environment respects individual
differences and recognizes each employee as an integral member of
our company. Our workforce reflects these values and celebrates the
individuals who make up our growing team.Gilead provides a work
environment free of harassment and prohibited conduct. We promote
and support individual differences and diversity of thoughts and
opinion.For Current Gilead Employees and Contractors:Please log
onto your Internal Career Site to apply for this job.
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Keywords: Gilead Sciences, Inc., San Mateo , Senior Director, Clinical Application & Data Services, Healthcare , San Mateo, California
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