Director, IT Applications

Position Overview

Nektar has an exciting opportunity for a Director, IT Applications to join their team.

This is a key position in the R&D application group of the Nektar IT organization.

As such, this position is responsible for the management, implementation and support of critical systems for Nektars departments (Manufacturing, Data Management and Clinical Operations).

This position also serves as an IT liaison to the business and translates their business requirements into technical solutions, processes and procedures as appropriate.

This role is the hands-on Technology Lead/ System Owner across multiple initiatives, taking on IT System Ownership for identified platforms/systems and collaborating closely with various business departments, other IT resources and our vendors.

This role is key to the delivery of current-state system improvements and future-state requirements driving innovation and seeking new technical solutions contributing to the Applications portfolio.

Finally, this position provides leadership in system delivery/implementation, ensuring GxP compliance within Nektars SLC framework, tools and procedures.

This position contributes to and supports the company’s research and development efforts to create high value therapeutics to address unmet medical needs.

Essential Duties and Responsibilities:

Works on complex problems or data requires an in-depth evaluation of various factors.

Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results.

Establishes and assures adherence to budgets, schedule, work plans, and performance requirements.

Designs and monitors the planning, configuration, and deployment of Wonderware, PLC, CMMS, LIMS, ELN, SAAS Clinical Systems like EDC, eTMF, RIM, in support of manufacturing, laboratory and clinical functions and processes.

Serves as Technical Expert for system design, database structures and relationships, study setup and workflow configuration changes, security management, and configuration updates/changes.

Oversees system maintenance, releases and upgrades, including the ability to design and develop custom reports per business needs with strict adherence to regulatory and compliance requirements (e.g.

GxP Validation).

Facilitates sessions for business requirements gathering and design / configuration workshops and provides technical assistance for integration between various systems.

Suggests process improvements to reduce operating time, improve efficiency or make data adjustments either through Business process adjustments and/or System changes.

Establishes relationships with key Business SMEs, recommends solution and plan, performs complex diagnosis of problems and root causes.

Notifies Business and IT Management on all process and system changes including vendor releases, new features, bug fixes and resolutions, providing training related to these items as appropriate.

Develops/assists project plans, leads project teams, develops internal procedures (SOPs), tools, and documents to provide a high level of application integrity and availability ensuring timely and effective support.

Assists in system documentation including requirements, scope, specifications, test plans and scripts, and procedures.

Participates in product evaluations (RFP/RFI), vendor selection, negotiates price and support options, and fosters vendor partnerships.

Responsible for administration, operational support including user, security management, data integrity, and maintaining the validated state of IT applications to ensure compliance to regulatory standards. Responds to critical issues during off hours when necessary and provides backup for other analysts as required.

Responsible for timely closure of Exception reports, CAPAs and Deviations, review and approval of controlled documents, policies, procedures and Work Instructions.

Represents as System Owner in the event of Regulatory Audits and Inspections (Internal and External).

Stays current with technological developments in Safety space, including reading publications, participating in on-line user communities and attending conferences and workshops. This role assists in team’s work load and is passionate about system implementation, maintenance, and compliance. Develop annual budget for respective business areas. Create and implement solution roadmaps for business areas with ability to lead large business initiatives. Other duties as assigned.

Minimum Qualification Requirements:

• A minimum of a Bachelors’ degree in Computer Science, Information Technology, or related discipline is required.

An advanced degree is highly preferred.

• A minimum of 13 years practical work experience with deep knowledge of GxP Applications, processes/procedures, and regulatory standards including implementing and supporting regulated systems in a life sciences/healthcare organization.

• A minimum of 8 years practical work experience as a GxP IT Applications Manager supporting system implementations and deployments for EDC, SAS, eTMF, RIM, CMMS, LIMS, ELN.

• 10 years of management experience desired.

Familiarity with Business Process Management (BPM) and Collaboration tools is preferred.

Understands relational databases and BI reporting tools.

Experience in SQL is preferred.

• 3+ years developing and executing strategic plans and project portfolios

• 4+ years of performance management across a globally distributed team, managing line managers, mentoring and growing direct reports to the next level of management

• Familiar with Enterprise wide systems implementation and support.

Familiarity with AWS or Azure preferred.

Familiar with drug discovery, translational medicine, and the IND/NDA process.

• Strong knowledge of procedures/ best practices related to FDA Regulations, SOX, EU GMP Annex 11, 21 CFR Part 11, CSV, GAMP 5, cGxP (cGCP, cGLP, cGMP) practices required.

• Familiar with System lifecycle (SLC) experience in a regulated environment.

Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies.

• Ability to articulate technical problems and business value to a wide business audience.

Ability to troubleshoot issues and work independently with minimal supervision.

• Must be able to demonstrate strong analytical and problem-solving capabilities.

Detail oriented and leads delivery of projects ensuring positive customer satisfaction.

• Excellent oral and written communication skills are required.

Must possess and demonstrate strong leadership, influencing and organizational skills.

• Self-motivated with high degree of initiative and excellent follow-up skills.