The Director, Standards and Database Design Lead is a management and leadership role responsible for establishing and governing Tyra’s clinical data standards and overseeing the design, build, and validated state of Tyra’s clinical data management systems. Reporting to the VP, Data Management, this role sits on the Data Management Leadership Team (DMLT), contributing to the strategic development of the department while being accountable for the quality, consistency, and inspection readiness of database builds across all clinical trials. The role governs the standards framework that study builds are designed against, owns build delivery and quality, and manages the vendors and budgets that support build execution.

The role requires in-depth expertise in clinical data standards (CDISC: CDASH, SDTM, ADaM, controlled terminology), study database design and EDC build, CRF/eCRF design, and the path from data collection through submission-ready datasets, with strong command of inspection preparedness. This role serves as the point of contact for EDC vendor management and operates independently within established Tyra Biosciences procedures. This is a management and leadership role with no direct reports initially; as the department and company needs evolve, the incumbent is expected to build and lead an in-house study build team.

Essential Functions and Responsibilities

· Establish and govern Tyra’s clinical data standards in accordance with industry best practices and Health Authority guidance and regulations, owning the end-to-end standards framework and libraries (CDASH, SDTM, ADaM, CRF/eCRF library, controlled terminology, and edit-check libraries), including versioning and change control, and keeping current with evolving CDISC standards.

· Establish the necessary workflows and supporting process documentation to operationalize standards, ensuring consistent, repeatable, and inspection-ready execution across all studies.

· Develop and maintain the systems, tools, and tracking mechanisms used to manage the department’s databases and data flow, providing leadership with clear visibility into build status, quality, and validation state.

· Lead efforts for standards-driven build deliverables, including eCRF design, edit-check specifications, listings and reports, validation, and User Acceptance Testing (UAT), from specification through release and amendment.

· Serve as the point of contact for database builds and post-production changes, overseeing the database impact of protocol amendments and ensuring controlled, well-documented change management.

· Maintain the standards and CRF/eCRF library and serve as the Clinical Data Management System (CDMS) business owner, defining configuration standards and governing platform use across the portfolio.

· Hold accountability for keeping all clinical data management systems in a continuous state of validation, ensuring compliance with 21 CFR Part 11 and applicable Health Authority requirements in collaboration with Tyra IT.

· Direct the development of reusable templates and standard study shells to accelerate builds and maintain consistency across studies.

· Provide leadership for EDC and related DM systems (EDC, ePRO/eCOA, RTSM, CTMS), and lead the evaluation, selection, and governance of platform and standards-management technology.

· Define and execute the strategy for transitioning CRO-hosted studies in-house, assessing remaining runway, submission proximity, and migrate-versus-close-out trade-offs.

· Provide strategic oversight of CROs and build/platform vendors, including selection, scope, KPIs, validation and UAT, and accountability for quality and timeliness.

· Lead standards decisions across Data Management, Biostatistics, Programming, Clinical, and Quality, and partner with Data Management leadership to align standards and builds with operational needs and timelines.

· Ensure standards, SOPs, and documentation meet GCP, GCDMP, ICH, 21 CFR Part 11, and FDA/EMA requirements, and drive inspection readiness.

· Own the build, platform, and vendor budget; forecast and reconcile spend and provide cost input to insource-versus-outsource decisions.

· Stay current on industry innovation and advancements in clinical data standards, database design, and supporting technologies, recommending improvements that advance departmental capability.

· Dependent upon department and company needs, build out and lead an in-house study build team, including hiring, onboarding, development, capacity planning, and performance management.

· Contribute to the strategic development of the department as a member of the Data Management Leadership Team (DMLT).

· Other tasks as assigned by management.

Required Education & Experience

· A 4-year degree (BA/BS) from a recognized university in Life Sciences, Computer Science, Data Science, Statistics, or a related field. Advanced degree preferred.

· 12+ years in clinical data management (biotech, pharma, or CRO), with significant time in study design, database build, and/or data standards, including establishing or maturing an in-house build or standards capability (ideally insourced from a CRO); sponsor experience preferred over CRO.

· 3+ years of people management and leadership experience, including building or scaling a team.

· Deep knowledge of CDISC standards (CDASH, SDTM, ADaM, controlled terminology) and the full clinical data lifecycle from data collection through analysis-ready datasets.

· Practical experience designing studies from reusable standards and components, and authoring eCRF, edit-check, listing, and validation specifications.

· Proficiency with commercial EDC platforms (preference given for Medidata Rave and Veeva Vault EDC/CDMS), including CRF/eCRF design and edit checks.

· Demonstrated experience maintaining systems in a validated state in accordance with 21 CFR Part 11, including UAT and computer system validation practices.

· Experience integrating external and specialty data (central labs, imaging, biomarkers, ePRO/eCOA).

· Applied knowledge of GCP, GCDMP, ICH, 21 CFR Part 11, and FDA/EMA/Health Canada requirements, with experience supporting regulatory submissions and inspection readiness.

· Oncology and/or pediatric (special-population) study experience preferred.

· Experience across Phases I through III and toward submission.

· Proficiency in use of Microsoft Suite products for gathering and communicating information to cross-functional team members.

· Demonstrated ability to work independently and in a team environment, and to lead through influence without direct authority.

· Excellent project management and organizational skills in a clinical trials setting.

· Excellent interpersonal skills.

· Excellent communication and presentation skills, both documented and verbal.

Pay Range and Benefits

Base Salary Range: $218,669 - $230,408USD (Dir Level)

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

What we offer US-based Employees:

• 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.