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.
Job Title: Director/Senior Director, Clinical Operations
Reports to: VP, Clinical Operations
Employment Type: Full-Time
Location: United States
FLSA Status: Exempt
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
- 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.
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