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Director, Pharmaceutical Information Systems

Norwood, MA

Posted: 10/31/2018 Job Category: IT Job Number: 2197

The Director, Pharmaceutical Information Systems (a newly created position based on growth) will manage infrastructure and resources to meet organizational IS needs. The person in this role will be responsible for working cross-functionally with all departments to identify long-term, scalable, practical solutions as the company grows. This person will act as a trusted business liaison, establishing close partnerships with colleagues across multiple disciplines to translate business needs into state-of-the-art solutions. This role has a focus on implementing clinical software systems and maintaining and enhancing the integrity of our Client’ s clinical data as they continue to progress through clinical trials.

The successful candidate must have prior experience working in Life Sciences and the ability to select, implement, manage and support other key initiatives and systems such as clinical systems, document management software, ERP and Quality Management Systems (QMS). This person will bring significant prior experience as a leader, defining and delivering IS solutions for Corporate, R&D and Quality in a Life Sciences setting, including experience with solutions supporting discovery through preclinical and clinical development.

PRIMARY RESPONSIBILITIES:
  • Lead development and maintenance of Client’ s IS systems with a focus on clinical software and data to ensure compliance with applicable regulations, guidance and GxP
  • Develop and lead a high-quality team of IS professionals by fostering a culture of collaboration and support through coaching and mentoring and successfully translating business requirements into team deliverables, individual goals and objectives
  • Oversee contingency planning and IT security and compliance by establishing controls and processes in support of data security, SOX and other relevant regulatory requirements including 21 CFR Part 11 and GDPR
  • Manage the purchasing of IT equipment and services as well as budgets
  • Maintain databases and documentation systems supporting Clinical Operations
  • Advise, guide development on, deploy and support Clinical systems
  • Advise, guide development on, deploy and support Document Management software
  • Advise, guide development on, deploy and support ERP Systems
  • Support System Development Life Cycle and GxP Computer System Validation projects in Quality Assurance
  • Manage the IS document management function
  • Develop, track and regularly report metrics around key performance indicators (KPIs)
  • Oversee SOX and other regulatory activities
  • Drive IS compliance programs related to GxP, Data Integrity, SOX and other regulatory requirements, and privacy
  • Define and promote IS policies, procedures and standards that align with regulatory requirements and industry best practices
  • Manage IS strategy, application roadmap, and project portfolio for R&D functions, e.g., lab and research informatics solutions (ELN, LIMS, CDS, Compound registration/inventory, Assay data management, SAR, PK/PD), clinical informatics (EDC, Data Management, eTMF, RIM, Adverse Event, SAS), and Quality solutions (QMS, LIMS)

REQUIREMENTS / QUALIFICATIONS:
  • BA/BS Degree required
  • 10+ years Information Systems leadership with experience in Life Sciences setting required
  • Ability to work in a very dynamic environment with a clear sense of urgency, manage competing priorities and deliver on commitments
  • Strong understanding and experience with Clinical Software, Clinical Data, Document Management Systems and Quality Management Systems
  • Comprehensive knowledge of essential IT functions including: network infrastructure, storage, servers, databases, cloud computing, data center operations, disaster recovery, security, telecommunications, SaaS solutions and vendor management
  • Proven experience building, leading and managing a high-performing IT team consisting of onsite resources, contractors, consultants and managed services providers
  • Experience managing IT projects and application portfolios with a demonstrated record of delivering projects and services that meet business objectives on time and on budget
  • Experience in financial management and budget planning as well as contract negotiation and vendor management
  • Strong communication and collaboration skills are a must
  • Experience in supporting a global organization managing incident, problem and request workflows

Lisa Madden
Recruiting Consultant

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