Senior Manager

Description:

The Sr. Manager R&D Information Systems will typically act as the technical lead within Patient Safety and / or manage a team of direct reports. This includes interpreting and / or developing systems specifications to develop, enhance and maintain information systems architecture, applications and functionalities. The Sr. Manager is required to design, develop, test, validate, maintain and improve R&D information systems, which involves additional responsibilities for preparing and delivering operating instructions and user training, compiling and managing other technical documentation, analyzing and evolving systems capabilities, and partnering with other Gilead Information Technology(IT) groups to enhance and improve R&D systems and related technical infrastructure. Good Practice quality guidelines and regulations (GxP) systems validation and user acceptance testing is also a specific responsibility here. The Sr. Manager may also provide technical support during regulatory inspections and internal audits. The Sr. Manager will work directly with internal and external customers to fully diagnose their technical needs and provide technical support for business applications or systems and may lead others in the development and / or maintenance of business applications and systems.

System Related Development

Essential Duties And Job Functions

Author complex Reports in IBM Cognos Reporting Tool using established policies and standard methodologies.
May act as the technical lead for the assigned business area(s) and /or manage a team of direct reports of increasing size, different geographies with increasingly complex assignments,
Manage and supervise a team of 3 or more direct full time reportees, including goal settings, performance review and appraisal.
When applicable, provide matrix management of small teams. Mentor less experienced colleagues.
Work directly with internal and external customer groups to identify short- and long-range business and technical objectives for the assigned area(s).
Recommend technical solutions to meet short- and long-range business needs. Lead development and manage execution of the short- and long-range technical roadmap for assigned business area(s). 
Oversee or otherwise lead specific projects and /or acts as a core project team member.
Be accountable for achieving business and technical objectives for assigned area.
Act as a technical spokesperson to the assigned area and based on area of expertise.
Oversee and guide or otherwise configure and develop systems applications and solutions, which may include responsibilities for defining the technical solution architecture.
Oversee and guide testing, user or processes activities, including refining applications or other solutions to align with business process needs. Where applicable, performs validation of GxP-related activities to ensure compliance with regulatory requirements.
Work directly with user groups and IT to enhance R&D applications and systems, such as reducing operating time and improving efficiencies, and coordinate infrastructure requirements with IT.
Oversee or otherwise authors technical documentation, business process documentation, user acceptance testing and / or validation test cases and delivery of user training.
Ensure business processes are created or updated and maintained to align with business and information systems needs and compliance requirements.
Independently create project budgets and resource plans for assigned projects, seeking advice as needed. Identifies cross-project synergies to leverage efficiencies and ensure consistencies where appropriate.
Organize, prioritize and coordinate multiple activities to meet project timelines.
Ensure assigned work complies with established practices, policies and processes and any regulatory or other requirements.

Technology

Extensive understanding and application of technical principle, theories, and concepts in reporting tools
Advanced hands-on experience in IBM Cognos
Ideal candidate must be self-motivated with a proven track record in BI application and data integration technologies and comfortable working in a fast-paced organization with rapidly growing business needs. Candidate must be organized and analytical, adept at working in a team environment, able to design and implement a project schedule, and able to handle multiple priorities .
Proven effectiveness managing technical projects and teams in a business environment. 
Multiple years of experience leading small to medium-size technical projects and project teams.

Preferred Qualifications Are

Good understanding of Safety and/or Clinical Database using tools like Argus, etc.
Previous experience with safety reporting and regulatory compliance and experience with international safety. Conversant with and understands current Pharmacovigilance regulations.
Strong presentation and communication skills.
Extensive understanding and application of technical principle, theories, and concepts in relational databases and SQL. Capable of independently writing PL/SQL queries when needed.
Demonstrate good judgment and pragmatic approach to delivering software that balances architecture activities across company needs, business constraints and technological realities
Should have participated in, and be familiar with, Agile (Scrum) project methodology and practices
Experience in data integration best practices.
5+ Years’ experience in managing and supervising a team of 3 or more direct full time reportees.

Additional Knowledge, Skills

Pharma experience is preferred, especially working with Research and Development/R&D/Development Operations functions (Drug Safety, Biometrics, Clinical Operations, Clinical Data Management, Epidemiology)
Experience working with validated/qualified applications is preferred
Work closely with different functional areas and project teams to identify and document reporting / Data interface requirements
Collaborate within IT to understand the data sources necessary to implement the planning and reporting applications interfaces requirements
Help drive testing activities to ensure accuracy and validity of data and reports across all boundary applications.
Has extensive knowledge of business information and technology requirements, regulatory requirements and technical solutions to meet business needs of increasing complexity.
Ability to lead and influence programs, projects and / or initiatives. Strong interpersonal skills and understanding of team dynamics. Strong negotiation and conflict resolution skills.
Ability to understand and communicate technical and/or business elements in a clear and concise manner. 
Proven ability to work successfully in a team-oriented, highly matrixed environment.
Strong quality-orientation and attention to detail and accuracy.
When needed, ability to travel.