Job Description

Tyra Biosciences, Inc. is seeking a highly motivated Director of IT, R&D Business Partner. This role will serve as the strategic and operational IT leader for the GxP-regulated business systems supporting Quality, Regulatory Affairs, Clinical Operations, Research & Development, and laboratory functions. This role is responsible for evaluating, implementing, validating, and administering the scientific and clinical systems, data infrastructure, and laboratory instrumentation that power the company's drug development programs. As the company advances into Phase 3 trials, this individual will play a critical role in ensuring systems are compliant, scalable, secure, and fit for the demands of pivotal-stage development and future commercial readiness.

This is a hands-on, high-visibility role for a team member who is equally comfortable setting technology strategy and personally troubleshooting a lab instrument integration or a CSV deliverable. The ideal candidate has direct experience in a GxP-regulated biotech or pharma environment and understands the unique systems needs of R&D, Clinical, and Regulatory functions.

Job Responsibilities:

• Administration, maintenance and ongoing support for Quality, Regulatory, Clinical and related systems and platforms.
• Support and monitor documentation control processes and systems including:
• Build training assessments into training compliance requirements
• Notify departments of new/revised document effective dates
• Create and manage enterprise-wide document templates
• Oversee schedule for documentation review
• Create and revise relevant IT policies and procedures as needed.
• Provide new hire/onboarding training relating to the procedures and compliance with the use of R&D systems.
• On-board and off-board employees in R&D systems.
• Troubleshoot issues and assist with implementation of effective solutions and corrective actions.
• Responsible for change management of systems, including configuration changes, training improvements, and efficiency opportunities, for continuous improvement.
• Responsible for software system upgrade activities and release management.
• Identify and drive continuous improvements to R&D systems for process efficiencies and improved compliance.
• Manage and review user access to R&D systems with business owners.
• Drive internal inspection readiness activities in preparation for potential regulatory health authority inspections.
• Oversee the management of vendors and supplier qualification and documentation.

Qualifications:

• Bachelor's Degree or 10+ years of successful IT related experience in the life sciences field.
• Understanding of GxP regulations and current industry practices.
• Comprehensive knowledge of quality principles and systems, audit, procedures, and equipment within a biotech environment.
• Demonstrated ability to effectively communicate information and ideas to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants.
• Working knowledge of AI tools, security and governance.
• Advanced experience using Microsoft Word, Excel, PowerPoint, PowerBI
• Experience using an electronic document management system (e.g., Veeva Vault, SharePoint, Box etc.).
• Knowledge of GxP concepts.
• Ability to work independently and as an effective and engaged team member in a fast-paced environment.
• Strong initiative, follow through, and attention to detail.
• Ability to work well in a deadline-driven environment and be flexible in a dynamic environment.
• Experience in a fast-paced, agile biotech environment.
• Ability to effectively communicate and share knowledge with cross-functional teams.
• Proven ability to work under tight deadlines and pressure.
• Must be highly organized and efficient to manage multiple tasks.

Pay Range and Benefits

Base Salary Range: $222,012 - $247,723

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Empl oyees:

• Competitive base, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Job Type: Full-Time

Work authorization : United States (Required)

Work Location: Remote

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.

Job Tags

Similar Jobs