Associate Director, Clinical Quality Assurance & Quality Systems

Summary of Position:

The successful candidate will be actively involved in helping build the Clinical Quality Assurance (QA) systems at Aravive. This individual will have the responsibility for GCP Auditing in addition to establishing, implementation and management of the Clinical Quality Systems training, vendor qualification, quality metrics tracking and reporting. The position will also include working closely with Clinical Operations to provide Clinical Study support related to GCP QA. The successful candidate will have a thorough knowledge of Quality Management System, associated regulations, and experience in the QA department of a biopharmaceutical company. Aravive is a fast-paced, small organization and the ability to be productive and successful in an intense and collaborative work environment is critical.

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Job Title:  Associate Director, Clinical Quality Assurance & Quality Systems

Reports to:  Senior Director, Quality Assurance

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  October/November 2021

  • Lead development of trial oversight plans and periodic reviews of risk; communicate/report risks and issues to the Senior Management
  • Participate on clinical study teams and support development of clinical documents and systems in compliance with GCP, regulatory requirements and internal policies/SOPs
  • Develop and execute annual GCP audit plans
  • Provide guidance during development and execution of Corrective and Preventive Actions (CAPAs) for GCP and PV audits
  • Assess and manage significant issues as they arise and manage risks to quality at a study level
  • Identify improvements that support quality, compliance with regulations and company standards; policies and procedures through partnership with internal and external stakeholders; Development Line Functions and QA groups
  • Lead and participate in GCP audits for investigator sites and vendors
  • Develop and/or review audit reports followed by audit certificates
  • Provide interpretation of GCP regulations and company process standards, guidelines, policies and procedures to relevant personnel
  • Manage the implementation of the electronic quality management system (EQMS)
  • Develop and maintain Standard Operation Procedures (SOPs) Policies, Job-Aids and other related documents
  • Implement improvements to existing GXP Standard Operation Procedures (SOPs)
  • Manage the GCP training program and provide training as required including the annual GCP training
  • Manage and maintain the vendor qualification program and GCP contract service provider audits
  • Maintain quality agreements with contract service providers/vendors
  • Position will require travel for auditing and/or company meetings and trainings

Required Skills Qualifications:

  • Bachelor’s degree with at least 10 years or Master’s degree in scientific discipline with at least 8 years experience is required in the biopharmaceutical industry in Clinical Quality Assurance
  • Experience with Oncology is a plus
  • Strong knowledge of Good Clinical Practice, 21 CFR Part 11, ICH guidelines and FDA regulations
  • Strong technical writing skills
  • Strong knowledge of cGCP requirements including ICH guidelines and specific regulatory authority requirements (FDA, EMA, PMDA, etc.)
  • Excellent oral and written communication skills
  • Excellent organization skills with ability to prioritize tasks

Benefits:

  • Medical, Dental, Vision, 401(k)

Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.

Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer and fibrosis. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.

Please send resumes and cover letters to info@aravive.com

Director/Senior Director, Clinical Operations

Summary of Position:

This position has responsibility for operational leadership relating to the direction, planning, and execution of clinical trials. The Director/Sr. Director will work internally across functions and externally with study vendors and clinical sites to ensure Aravive clinical trials are completed in accordance with the study protocol and Good Clinical Practice (GCP). The successful candidate will provide day to day oversight of CRO and other vendors as it relates to the clinical trial(s), including site start-up, clinical monitoring, data review and quality, and compliance.

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Job Title:  Director/Senior Director, Clinical Operations

Reports to:  VP, Clinical Operations

Employment Type:  Full-Time

Location:  United States

FLSA Status:  Exempt

Date:  TBD

Required Skills & Abilities:

  • Ensure the timely execution of clinical trials from conception through final clinical study report. This will generally involve close supervision of external CROs and vendors who will have responsibility for site interaction, site monitoring, data management, biostatistics, medical writing, pharmacovigilance, and other critical activities.
  • Establish and maintain good working relationships with clinical study site personnel to ensure adherence to protocols and GCP, provision of quality data and adherence to study timelines
  • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
  • Provide efficient updates on trial progress to senior leadership with respect to monitoring and data review activities, CRO oversight, quality standards and risk mitigation.
  • Prepare and manage protocols and protocol amendments
  • Assist with preparation of key documents e.g. Investigator Brochures, FDA Briefing Documents, internal or external presentations, etc.
  • Interface with other departments at Aravive, including Medical, Data Sciences, CMC, and Regulatory, among others
  • Effectively train and present information
  • Detail oriented and accurate, excellent communication skills both written and spoken.
  • Write reports, procedural manuals and business correspondence
  • Communicate status and escalate ongoing issues to ensure timely decision-making
  • Ability to develop and manage budgets
  • Able to support the development of clinical monitoring infrastructure including standard operating procedures (SOPs), working practice documents, vendor oversight standards
  • Motivated to learn or advance own expertise and value

Qualifications:

  • BA/BS in scientific field of study. Advanced degree a plus.
  • 12+ years of clinical operations experience in a CRO or pharmaceutical company
  • 5+ years of trial management experience
  • 5+ years of oncology experience

Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.

Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.

Please send resumes and cover letters to info@aravive.com