Director of IT Solutions, Process & Delivery

Candel TherapeuticsNeedham, MA
29d$215,000 - $235,000Hybrid

About The Position

The Associate Director/Director, Information Technology is a key leader within the Information Technology organization working on both tactical and strategic goals, projects and support related to business systems across the organization. This role will also help develop SOPs and Procedures within the IT organization, especially as it relates to IT Lifecycle Management and System Development LifeCycle activities. This role is ideal for an IT leader who enjoys building strong relationships, solving complex problems, and owning initiatives from concept through execution. You will help shape how systems are selected, implemented, governed, and continuously improved while supporting the day to day technology needs of a fast paced biotech environment.

Requirements

  • Minimum undergraduate degree in Computer Science or related discipline and at least 8 years progressive information technology experience in a similar role, of which at least 3 years of the experience is in a leadership/people management capacity.
  • 15+ years experience in a similar role at a clinical or commercial stage company in the biotechnology or pharmaceutical industries is required.
  • Excellent hands-on project management and organizational skills.
  • Experience in FDA 21 CFR Part 11 and GxP-regulated environments in life sciences, including GxP IT Systems – this is a must have.
  • Experienced in vendor management in project team settings, actively bridging the gap between the project team’s needs and the vendor’s product.
  • Extensive experience working in and supporting a Microsoft environment with O365.
  • A broad knowledge base of current technology including an understanding of on-premise and cloud architectures in the biotechnology or pharmaceutical industries.
  • Excellent written and verbal communication skills with the ability to explain highly technical information in a concise and effective manner to an audience of varying technical aptitude.
  • Strong interpersonal skills that supports quickly building rapport with varying internal projects teams and external vendors; ability to manage competing interests in a professional, collaborative and solution-driven manner.
  • Proven ability to quickly diagnose and respond to emergency failures in a resourceful and calm manner.
  • Ability to work independently, as a team member, and across the organization with varying levels of employees.
  • Ability to work flexibly in a fast-paced environment with a strong work ethic and positive attitude.
  • Strong analytical, problem-solving, and negotiation skills.
  • Demonstrated ability to lead continuous improvements in business processes.

Nice To Haves

  • Experience leading IT lifecycle management and SDLC initiatives.
  • Comfort working in lean, fast paced environments where priorities may evolve.
  • A leadership style that balances accountability with approachability and support.
  • The ability to build trust and credibility across scientific, operational, and corporate teams.

Responsibilities

  • Develop, maintain, and ensure consistent application of policies and procedures related to system application selection (RFI/RFP, contracts, SOWs), implementation and maintenance, ensuring compliance with business standards and project management best practices.
  • Actively learn and understand the Company’s end to end business processes and how data is transferred from one system to another, in order to map out and plan systems and applications integrations.
  • Work with internal stakeholders and external vendors to identify, evaluate, and recommend commercially available applications to support business needs, collaborating with department project leads to develop the formal business cases for proposed system implementations, replacements or enhancements.
  • As the IT business partner for system applications evaluations and implementations, ensure key factors such as level of diligence, systems integration, data security, risk, etc. are considered and appropriately documented as part of the evaluation process.
  • Act as the IT project lead on Saas implementations or enhancement projects, working collaboratively with other project team members to ensure successful delivery of the project. Coordinate project priorities, timelines, and resource allocation with multiple stakeholders. Where needed, provide IT support for functional area application implementations and system enhancements.
  • Develop and maintain required GxP and non‑GxP SDLC documentation—including traceability, design and configuration specs, UAT scripts, security and validation deliverables, and change‑control artifacts—for assigned SaaS and in‑house databases
  • In collaboration with the Legal department, negotiate and maintain service level agreement contracts with external vendors, where applicable.
  • Review, update and document the change management process for all applications across the organization to ensure consistency in approach, approvals, and other considerations.
  • Facilitate and troubleshoot issues related to business applications.
  • Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
  • Other duties as assigned.
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