Senior Director, Clinical Quality Assurance

Tyra Biosciences, Inc. is seeking a highly motivated Senior Director of Clinical Quality Assurance to make significant contributions to oncology and rare disease programs with high unmet medical needs. The successful candidate will be highly organized, self-motivated, and thrive in a dynamic, cross-functional start-up environment. The Senior Director, Clinical QA is responsible for hands-on, compliance, and strategic support of Tyra clinical studies according to Good Clinical Practices (GCP) aligned with registrational and global regulatory readiness. This position will also contribute to compliance of Good Laboratory Practices (GLP) and Good Pharmacovigilance Practices (GVP), as needed. This pivotal role will support on-going and future clinical studies associated with Tyra’s clinical programs including Phase 1 through Phase 3 studies while applying risk-based principles through successful collaboration with intern and external cross-functional study staff.

The Senior Director, Clinical QA will be responsible for leading clinical quality tasks and initiatives that will advance Tyra’s clinical programs in preparation for registrational studies. This role will include the implementation of Quality processes, inspection strategy and readiness activities, support for auditing clinical vendors, and partnership with key clinical cross-functional groups (e.g., Clinical Operations, Clinical Development, Biostats, Data Management, Clinical Pharmacology, and Regulatory Affairs) to ensure compliance and continuous process improvement.

Must have extensive experience in GCP, GLP, and GVP regulations and current industry practices

Job Responsibilities:

• Provide GCP guidance to internal stakeholders and Study Management Teams as it relates to matters of quality
• Build, develop, and maintain working relationships with internal/external partners and study team members by providing real-time quality guidance and support.
• Develop and implement risk-based GCP audit strategies across clinical programs and/or studies.
• Lead, manage and/or support the development, revision, review, and implementation of GCP quality standards and controlled documents (e.g., SOPs, Work Instructions, Forms, and Templates)
• Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program.
• Support, conduct and/or oversee audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.g., study specific audit plans, reports, corrective actions). For those audits conducted by external auditors, lead coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs.
• Partner with internal stakeholders to provide sponsor oversight of clinical vendors and investigator sites.
• Conduct gap analysis and/or participate in risk assessment for critical study level activities that may impact subject safety and/or the integrity of clinical data including but not limited to:
• Study Design and Protocol Requirements
• Clinical Sites, Vendors, and Service Providers-Transferred Obligations and performance
• Internal processes (e.g., vendor oversight)
• Conduct and/or facilitate investigations of GCP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to develop corrective and preventive action plans, as applicable.
• Lead Risk-Based Quality Management (RBQM) aligned with ICH E6 (R3)
• Manage and lead regulatory inspection readiness and inspection management activities while driving inspection-related process improvements. This may include:
• Project Management activities for Inspection Readiness initiatives.
• Complete Inspection Readiness activities including preparing internal teams, clinical sites and significant clinical service providers.
• Lead cross-functional teams to ensure a state of real-time inspection readiness.
• In collaboration with line function heads, ensure GCP, GLP, and GPV vendors comply with the applicable quality program and regulations or guidelines and are prepared for Regulatory inspections
• Partner with clinical stakeholders and subject matter experts for the implementation and management of Clinical Risk Management Program.
• Lead or contribute to Quality and Clinical Governance forums through the development and maintenance of key Clinical Quality Metrics for input into process improvement initiatives and/or presentation to Study Management Teams and Senior Leadership.
• Lead the development and delivery of clinical quality and compliance related training to internal functions. This may include coordination efforts in training events delivered by CQA and/or external consultants.
• Participate in quality and/or cross-functional process improvement initiatives, as applicable.
• Other duties as assigned by Quality Assurance Management.

Qualifications:

• Bachelor's Degree and 15+ years of clinical quality assurance or clinical operations related experience
• Extensive experience in GCP, GLP, and GVP regulations and current industry practices
• Comprehensive knowledge of clinical quality principles and systems, audit, clinical study processes, and procedures within study investigator sites and a clinical research organizational environment
• Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system related projects with high level / wide scope and complexity
• Demonstrated ability to effectively communicate information and ideas to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants
• Knowledge of computer software, including relevant applications such as MS Word, Excel, PowerPoint, SharePoint
• Advanced experience using Microsoft Word, Excel, PowerPoint, PowerBI
• Experience using an electronic document management system (e.g., MasterControl, Veeva, Trackwise, etc.)
• Enhanced knowledge of GxP concepts and guidelines
• Ability to work independently and as an effective and engaged team member in a fast-paced environment
• Superior communication skills both written and verbal with staff at all levels of the company enterprise wide
• Strong initiative, follow through, and attention to detail
• Ability to balance both strategic and tactical responsibilities
• Ability to work well in a deadline-driven environment and be flexible in a dynamic environment
• Experience in a fast-paced, agile biotech environment
• Excellent attention to detail
• 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: $255,859 - $275,000 USD

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.