Senior Clinical Research Associate

Summary of Position:

This position has responsibility for strategic and operational leadership relating to the direction, planning and execution of all monitoring activities associated with clinical trials ensuring the highest quality. The successful candidate will provide day to day oversight of cross-study monitoring activities, data quality, compliance to study protocols and GCPs for clinical studies being conducted globally. The individual is responsible for planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards and directs monitoring and compliance functions associated with study oversight. The individual will provide oversight of contracted monitoring teams and complete co-monitoring visits to ensure oversight, data integrity and determine compliance with IRB approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements.

___________________________________________________________________________

Job Title:  Senior Clinical Research Associate

Reports to:  VP, Clinical Operations

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Winter, 2020

Required Skills & Abilities:

  • Detail oriented and accurate, excellent communication skills both written and spoken.
  • Ability to work collaboratively with team members
  • Ability to work across numerous studies proactively identifying potential issues and managing relationships with CRO monitoring teams, supporting clinical sites, vendors and internal teams
  • Together with Management and Quality the individual implements a monitoring strategy to ensure compliance with all applicable regulatory requirements and makes recommendations to regarding the specific activities and resources required to support this strategy
  • Able to influence, negotiate, problem solve
  • Ability to write reports, procedural manuals and business correspondence
  • Able to serve as a resource to study leads, safety, data management and investigators
  • Able to provide guidance developing a comprehensive clinical research monitoring support infrastructure
  • Ability to effectively train and present information
  • Strong organizational skills able to fully outline tasks and bring clinical site activities to closure
  • Able to setup, maintain and audit Trial Master Files
  • Communicates status and escalates ongoing issues to ensure timely decision-making
  • Provides study-level hands-on direction and support as it relates to study conduct and timelines
  • 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
  • Experience directly monitoring oncology trials required
  • Motivated to learn or advance own expertise and value
  • Takes ownership

Qualifications:

  • BA/BS in scientific field of study
  • Completion of an accredited Nursing (RN), Physician Assistant, or Bachelor’s Degree in related healthcare, preferred and/or extensive clinical research
  • SoCRA Certified Clinical Research Professional (CCRP) or ACRP Certified Clinical Research Coordinator (CCRC) required. ACRP Certified Clinical Research Associate (CCRA)-preferred
  • A minimum of 12 years of clinical monitoring experience is required
  • A minimum of 6 years of oncology study monitoring experience required
  • QA, Regulatory, Auditing, Data management experiences a plus
  • Trained on numerous EDC systems
  • Therapeutic experience in oncology, Ovarian cancer experience preferred
  • Experience in all phases of clinical trials

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. 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

Senior Director, Clinical Operations (Europe)

Summary of Position:

This position has responsibility for strategic and operational leadership relating to the direction, planning execution, and conduct of clinical trials in Europe. The successful candidate will provide day to day management of clinical studies being conducted in Europe, managing relationship with CROs, clinical sites, vendors and internal teams.

___________________________________________________________________________________

Job Title:  Senior Director, Clinical Operations (Europe)

Reports to:  VP Clinical Operations

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Winter 2020

Required Skills and Abilities:

  • Ability to work across all aspects of clinical and proactively identify potential issues and put in plans to mitigate/avert
  • Ability to write reports, business correspondence, and procedural manuals
  • Ability to effectively present information
  • Strong organizational skills able to fully outline tasks and bring clinical trials to report
  • Detail oriented and accurate, good communication skills both written and spoken
  • Ability to work collaboratively with team members
  • Communicates program status, cost and escalates ongoing issues to ensure timely decision-making
  • Provides study-level hands-on direction and support as it relates to timelines and project delivery to cross-functions including clinical management, data management, clinical supplies, safety, regulatory affairs and quality
  • Ability to develop and manage budgets
  • Abel to support the development of clinical operations infrastructure including standard operating procedures (SOPs), working practice documents, vendor oversight standards, key performance indicators
  • Experience directly leading oncology studies and phase1b/2 oncology studies conducted globally and/or in Europe
  • Line management experience preferred
  • Motivated to learn or advance own expertise and value
  • Able to influence, negotiate, problem solve and drive results
  • Diligent, creative, entrepreneurial with the ability to independently execute
  • Takes ownership

Qualifications:

  • BA/BS in scientific field of study, Master’s degree preferred
  • A minimum of 12 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical or Biotechnology, is required
  • Experience managing clinical trials conducted in Europe and globally
  • A minimum of 5 years of oncology study experience
  • Prior monitoring and/or clinical project management experience is strongly preferred
  • Therapeutic experience in oncology, Ovarian cancer experience preferred
  • Experience in all phases of clinical trials through marketing submission

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

Associate Director, Clinical Quality Assurance

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.

_____________________________________________________________________________________

Job Title:  Associate Director, Clinical Quality Assurance

Reports to:  Senior Director, Quality Assurance

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Winter 2020

  • 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.
  • 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 may require occasional travel.

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

Vice President, Clinical Operations

Summary of Position:

The successful candidate will provide day to day management of clinical programs, managing relationship with CROs, clinical sites, overseeing data management, statistics, external experts, analyzing and integrating data.  This position has responsibility for evaluating and recommending clinical strategies, external resources, negotiating budgets for clinical activities, and working closely with Medical staff to assume current medical standards are embedded in clinical studies. The successful candidate will be responsible for updating senior management and the Board of Directors on critical activities and advising on development strategies. This position will also have responsibility for collaborating with development partners.

___________________________________________________________________________________

Job Title:  Vice President, Clinical Operations

Reports to:  Chief Medical Officer

Employment Type:  Full-Time

Location:  Remote

FLSA Status:  Exempt

Date:  Winter, 2021

Required Skills & Abilities:

  • Ability to work across all aspects of clinical and proactively identifying potential issues and put in plans to mitigate/avert.
  • Ability to write reports, business correspondence, and procedural manuals.
  • Ability to effectively present information and respond to questions from groups of personnel, including members of the Board of Directors.
  • Strong organizational skills.
  • Detail oriented and accurate.
  • Ability to multi-task and prioritize work assignments with no supervision.
  • Ability to work collaboratively with team members.

Qualifications:

  • Ph.D. or Pharm.D. required
  • A minimum of 10 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical or Biotechnology, is required.
  • Prior line management experience is required.
  • Prior monitoring and/or clinical project management experience is required.
  • Therapeutic experience in oncology
  • Vendor management
  • Experience in all phases of clinical trials through marketing submission.

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

Director, Statistical Programming

Summary of Position:

The successful candidate will be a technically strong SAS programmer with biopharmaceutical experience in oncology who can collaborate with members of cross-functional teams to support Data Management and Biostatistics functions, individual protocols and integrated databases planning for electronic submissions, oversight and guidance for CRO provider’s SAS programming services, and in-house ad hoc analyses as needed. Aravive is a fast-paced, small organization and the ability to be productive and focused in an intense and collaborative work environment is critical.

___________________________________________________________________________________

Job Title:  Director, Statistical Programming

Reports to:  Executive Director, Data Sciences

Employment Type:  Full-Time

Location:  US East Coast (NC preferred)

FLSA Status:  Exempt

Date:  Winter, 2020

Key Essential Functions:

  • Guides setup and oversight of CDISC compliant database structures for individual clinical trials in collaboration with Data Sciences leadership and our CRF data services provider.
  • Guides setup and oversight of CDISC compliant database structures for product-specific integrated databases suitable for e-submissions, in collaboration with Data Sciences leadership and our CRF data services provider.
  • Assists with identifying automated edit checks within EDC systems used for clinical trials data accrual.
  • Manages Aravive’s hosted SAS environment (software and data)
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements

Required Skills & Abilities:

  • Must have a thorough working knowledge of SAS software as used in oncology clinical trials
  • Knowledge of JMP Clinical preferred and expertise in providing publication-ready graphics from SAS and JMP Clinical
  • Fluent with writing and reviewing database and analysis specifications
  • Fluent with CDISC SDTM and ADaM guidances (SEND and NCI familiarity also helpful)
  • Ability to work independently with minimal supervision, manage a variety of tasks with competing priorities, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess strong project management skills
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Ability to communicate technical information in a clear and concise manner
  • Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
  • Excellent organization skills with acute attention to detail
  • Strong desktop computer skills for MS Office products

Required Qualifications:

  • Bachelor’s degree +8 years, Master’s Degree + 5 years, Doctoral Degree + 2 years of relevant SAS programming experience in the pharmaceutical industry, especially in oncology; advanced certifications in SAS a plus.  Title will be commensurate with experience.
  • Proven successful experience with SAS programming for data management and statistical analysis functions.

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

Senior Manager, Clinical Supply Chain

Summary of PositionThis position is responsible for managing global investigational drug supplies and managing the Bio-sample management infrastructure on a set timeline and in compliance to Good Clinical Practices.

Work will include but is not limited to overseeing daily operations of 3rd party vendors, creating work instructions and operating procedures (internal and external), and executing Bio-sample and investigational drug supply initiatives.  Ensure resources are in place to support clinical studies and supply chain projects. Manage/support cross-functional projects such as cross-functional process/system integration. Build processes that are scalable for future growth.

This individual will manage operational aspects of drug shipping, vendor contracting, sample receipts, distribution and accountability from multiple labs and clinical sites around the globe. He/she will act as a key resource and escalation point for study teams, distributors, and suppliers and contributes to the creation of strategy for clinical drug supply and sample management; translates strategic objectives into plans for team execution. Should work in a cross functional manner across study teams to develop consistent practices.

Must be knowledgeable of departmental and pharmaceutical industry best practices including Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices. Should be able to identify risks in supply chain, recommend mitigation plans to management, and implement solutions.

___________________________________________________________________________

Job Title:  Senior Manager, Clinical Supply Chain

Reports to:  Vice President, Clinical Operations

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Winter, 2021

Position Accountabilities:

  • Manage and prioritize daily workflow activities of 3rd party vendors supporting clinical study drug supply and clinical sample collection and processing.  This includes oversight of outsourced project work
  • Day-to- day oversight of global and local shipments of Investigational drugs and clinical Bio-samples
  • Develop and implement Standard Operating Procedures (SOPs) and work instructions that ensure full compliance with protocols in place
  • Manage sample operations for audit readiness
  • Manage multiple complex projects, business process development and technology and software deployments, improvements, and maintenance for all sample management systems.
  • Take lead role in inventory reconciliation, returns, discrepancies, lost in transit shipments, complaints, recalls and closeouts.
  • Represent sample operations at stakeholder meetings for ongoing and prospective projects to establish and influence project strategies and deliverables related to samples.  Stakeholders to include internal teams, Sponsor meetings, etc.
  • Manage milestones and timelines across projects, analyzes and communicates project risks and issues as necessary.  Adjust project plans, timelines or resources to ensure successful project delivery.
  • Assist in contract processes in conjunction with Project Directors in providing correct scope of work for initial contracts and identifying changes in scope in ongoing projects
  • Provide sample reporting and on-demand support for field sales, 3rd party vendors and internal customers.

Education, Behavioral Competencies and Skills:

  • Minimum five years relevant pharmaceutical experience required
  • 5 + years working in sample operations/accountability/compliance
  • 5 + years of clinical drug supply oversight experience
  • Experience with international import/export regulations for biologic materials
  • Experienced Investigational drug supply chain management
  • Trained on GCPs required, and GMP, GLPs desired
  • Experience with packaging/ labeling of investigational drug supplies required
  • Experience with IVRS, IRT setup
  • Experience with Oracle EDC software preferred.
  • Experience with sample management software and Microsoft project
  • Extensive knowledge with Microsoft Office applications is a must (Project, Excel, PowerPoint, Word)
  • Organization and time management skills required
  • Possesses strong attention to detail and analytical skills
  • Proven record of being detail oriented, possessing accuracy, and understanding quantitative issues.
  • Excellent analytical and technical skills.
  • Excellent oral and written communication skills.
  • Ability to multi-task.
  • Excellent problem-solving skills with consistent demonstration of sound judgment required.
  • Experience managing business operations and/or processes very desirable.
  • Strong understanding of auditing principles desired.

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. 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

VP Regulatory Affairs

Summary of Position:  The successful candidate will lead and direct the development and execution of worldwide regulatory strategies for Aravive’s products. The VP Regulatory Affairs will provide expert analysis and evaluation of all regulatory information, recommend approaches for resolving risks and improving regulations.   The candidate will also be accountable for effective regulatory submissions and communications/meetings with regulatory authorities.

_____________________________________________________________________________________

Job Title:  VP Regulatory Affairs

Reports to:  CMO

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  TBD

  • Advise internal clinical, non-clinical, quality and CMC departments on regulatory impact of development decisions
  • Work with Quality Assurance to ensure systems are maintained and in compliance
  • Communicate requirements and compliance obligations under applicable laws and regulations in the US and outside the US
  • Maintain regulatory affairs infrastructure including development of departmental policies and procedures
  • Direct submissions (IND, NDA, MAA etc.) and approvals
  • Lead contact with regulatory agencies for all communications and meetings.
  • Lead and write the development and submission of documents to regulatory agencies which will ensure our development goals are of high quality and on-time
  • Manage safety review processes and reporting of safety issues to the FDA
  • Responsible for management of the Regulatory Affairs department budget

Required Skills & Abilities:

  • Ability to work across all departments and proactively identifying potential issues and put in plans to mitigate/avert.
  • Ability to write reports, business correspondence, and procedural manuals.
  • Ability to effectively present information and respond to questions from groups of personnel, including members of the Board of Directors.
  • Strong organizational skills.
  • Detail oriented and accurate.
  • Ability to multi-task and prioritize work assignments with no supervision.
  • Ability to work collaboratively with team members.

Benefits:

  • Medical, Dental, Vision, 401(k)

 Qualifications:

  • Advanced degree preferred in a scientific discipline with at least 10 years of relevant regulatory experience; (B.S. or M.S. will be considered with at least 10 years of experience)
  • Demonstrated success in communication and negotiation with the FDA
  • Experience in collaborating with and managing outside partners and vendors

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