Associate Director, IT Applications

Location
San Francisco, CA, United States
Posted
Sep 11, 2018
Ref
3360-850-NB
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

The Sr. Manager, IT Applications will be responsible for the implementation and support of critical systems that enable the Nektar Research, Drug Development and PDM organizations to discover, develop, and deliver our therapies to our patients.

This role will be hands-on Technology lead and System Architect across multiple initiatives, take on IT System Ownership for identified platforms/systems and will collaborate closely with various business departments, other IT resources and our SaaS vendors. This role is also 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. This role will assist in team's workload, and will be passionate about system implementation, maintenance, and compliance.

Design and monitor the planning, configuration, and deployment of Nektar EDC/Clinical systems (Medidata Rave, DrugDev Spark or equivalent CTMS), Biometrics- SAS, IRT, Veeva-eTMF, Pharmacovigilance systems (Oracle Argus), Document Management Systems (Veeva) , Regulatory Systems (eCTDXPress, Veeva Submissions, PromoMats), and other associated systems in support of core R&D, PDM functions and processes ( may assist the Data-warehouses /Analytical platforms if needed)

Ability to develop solutions to complex problems that require a high degree of ingenuity, creativity, and innovation within the boundaries of industry compliance regulation. Drive consistency across IT investments by establishing configuration best practices and standards in taxonomies, lifecycles, workflows, security, etc. Facilitate sessions for requirements gathering and design / configuration workshops, and provide technical assistance for integration between various business systems. May develop project plans, organizes and leads project teams, monitors progress, and evaluates effectiveness on smaller projects. Develop and manage internal procedures, tools, and documents to provide a high level of application integrity and availability and to ensure timely, effective support. Author system documentation including requirements, scope, specifications, test plans and scripts, managing source code and operational run-books and procedures. Participates in product evaluations (RFP/RFI) , vendor selection, negotiates price and support options, and fosters vendor partnerships. Reconciles vendor driven enhancements with user requested improvements to determine appropriate level of vendor vs. in-house work necessary to meet user needs. Responsible for maintaining the validated state of R&D, PDM applications to ensure compliance to regulatory standards. Implementing and managing security or integrity and backup procedures and change management. Establish partnership with Business SME's/end users for project requirement, performs complex diagnosis of problems, providing solutions within area of responsibility, and/or through partnering with others in the Nektar IT department and/or vendor provided support. Coordinates implementation of fixes and enhancements and provides backup for other analysts as required. Responds to critical issues during off hours when necessary. Manage administration and operational support including user and security management, provide inputs to process improvements. Responsible for timely closure of Exception Reports, CAPAs and Deviations, review and approval of controlled documents, policies, procedures and Work Instructions. Represent as System Owner in the event of Regulatory Audits and Inspections (Internal and External). Stays current with technological developments in software development, systems and application support, as well as management and user support practices. This includes reading publications, participating in mail lists and on-line communities, attending conferences and workshops.

Required Skills: Familiar with drug discovery, translational medicine, and the IND/NDA process. Familiar with Enterprise wide systems (RIMS, CTMS, LIMS, EDMS) implementation and support. Familiar with Computer System Validation, SDLC and the Change Control Process in Life sciences industry. Comfortable working with Business Owners, IT QA, Business QA and end users with differing levels of technical expertise. Strong understanding of relational databases, database programming skills and tools. Ability to plan and coordinate multiple simultaneous application efforts, Quick learner, Analytical and problem-solving skills, with ability to work under pressure. Attention to detail, Self-starter / tenacious problem solver / highly motivated. Ability to take projects from design to long-term maintenance. Excellent communication and documentation skills. Knowledge and experience with systems development lifecycle and data modeling is required.

BS in a related field such as Information Technology/ Computer Science/ Software Engineering. A minimum of 8-10 years practical work experience in implementing and supporting regulated systems in a life sciences/healthcare organization. A minimum of 5 years practical work experience as an IT System Administrator is required with experience in a life sciences/healthcare organization. Working knowledge of FDA, EMA regulations such as Annex 11, 21 CFR Part 11, Part 210, 211; Computer Systems Validation and GAMP framework. Must understand the above standards and be able to deliver compliant solutions.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.