Clinical Scientist

Summary of Position:

This position has responsibility for directing and performing clinical data review activities for Aravive clinical trials. The Clinical Scientist will work internally across functions and externally with study vendors and clinical sites to ensure Aravive clinical trial data are complete, accurate, comprehensive, and consistent, in accordance with the protocols and eCRF Completion Guidelines. The successful candidate will lead day to day clinical data review tasks within Aravive, provide guidance to study personnel to ensure data are cleaned appropriately, and streamline data review processes across Aravive clinical trials.

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Job Title:  Clinical Scientist

Reports to:  VP, Clinical Operations

Employment Type:  Full-Time

FLSA Status:  Exempt

Required Skills & Abilities:

  • Lead the Integrated Data Review Team, including internal and CRO personnel, to ensure data are cleaned on a timely basis
  • Perform high quality clinical data review and identify clinical data insights through ongoing review of patient profiles and data tables/listings
  • Support study interim and final analyses as well as interim data cuts through ad hoc data review, including oversight of additional contract data reviewers as needed
  • Work collaboratively with the Clinical Operations Lead, Data Management Lead, and Medical Monitor for each study, to ensure an accurate group understanding of clinical data expectations
  • Provide data trends and analysis to study personnel, including training of CRAs and site staff as needed
  • Lead data review planning and strategy, including input on data tools such as the CRF and TLFs
  • Serve as a resource for study teams regarding scientific, clinical, and oncology questions, supporting Medical Monitoring
  • Issue, review, and resolve queries in EDC as required
  • Detail oriented and accurate, excellent communication skills both written and spoken.
  • Communicate status and escalate ongoing issues to ensure timely decision-making

Qualifications:

  • BA/BS in scientific field of study. Advanced degree (Master’s, PharmD, PhD) preferred.
  • 10+ years of clinical experience in a CRO or pharmaceutical company
  • 5+ years of experience in clinical science or clinical research, with a minimum of 3+ years experience in data review
  • 5+ years of oncology experience, including in-depth knowledge of NCI CTCAE and RECIST
  • Expertise in clinical data collection and reporting; demonstrated ability to use data systems and tools (e.g., EDC, Excel, j-Review or equivalent)
  • Proficient knowledge of GCP/ICH, Phase I-III drug development, and medical terminology

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 focused on treatments for cancer. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC. For more information, please visit our website at http://www.aravive.com.

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

Director/Senior Director, CMC

Summary of Position:

This position is responsible for leading the activities involved in all aspects of biological drug substance development and manufacturing from preclinical to clinical trial material production and ultimately to global product approval and commercialization. The candidate will provide technical expertise to manage multiple contract manufacturing organizations and third-party organizations as well as to internal stakeholders. The successful candidate needs to have expertise in global clinical supply management, including packaging and labeling and procurement of combination therapies and will be responsible for monitoring the CMC budget closely in collaboration with the finance team.

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Job Title:  Director/Senior Director, CMC

Reports to:  Chief Executive Officer

Employment Type:  Full-Time

Location:  United States

FLSA Status:  Exempt

Date:  TBD

Key Essential Functions:

  • Establish, manage, and lead the CMC development plan for drug substances and drug products from pre-clinical through commercial development
  • Coordinates timelines and deliverables through Program Management and other functions, as appropriate; Participate in product development project teams as CMC functional area representative
  • Direct/oversee contract manufacturing, analytical testing, packaging and labeling operations for the company’s drug substances and drug products. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to all manufacturing operations
  • Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
  • Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet corporate objectives
  • Provides comprehensive project analysis to senior management as required in the form of reports or presentations as needed
  • Provides and writes relevant documentation for regulatory submissions for global registration of product to ensure successful and timely approval
  • Works with Technical Operations/Quality and Regulatory Affairs to assure compliance to GLP, GMP and GCP requirements; develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc
  • Maintain knowledge of current best practices of biological manufacturing. Identify emerging trends and technologies and lead implementation/feasibility assessment, as appropriate
  • Coordinates with Technical Operations/Quality the review and audit vendors
  • Select third-party manufacturers working with Quality and Regulatory, negotiate effective supply/technical agreements. Identify contract analytical laboratory sites required to guide and support third party manufacturing relationships. Other duties and responsibilities as assigned
  • Position requires some travel

Required Skills & Abilities:

  • MS or PhD in biological sciences or engineering or BS degree in scientific field plus at least 10 years of experience
  • Experience in leading or being part of a team through the successful approval of a new drug in the US and/or Europe and/or Japan
  • Experience in leading meetings, teams, contract manufacturing organizations
  • Demonstrated management experience including employee development and leadership
  • In-depth experience with issues related to drug substance manufacturing is required
  • Involvement in regulatory interactions / filings involving biologics as well as combination products (drug/device)
  • Knowledge of current requirements for GLP, cGMP, and GCP is also required
  • Direct experience with regulatory submissions
  • Forward-thinking and creative with high ethical standards
  • Team player with leadership skills with ability to influence others to achieve successful regulatory filings and meetings.
  • Well organized and self-directed
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization

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 focused on treatments for cancer. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC. For more information, please visit our website at http://www.aravive.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

Manager, Clinical Sample Management

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 http://www.aravive.com.

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 Job Title:  Manager, Clinical Sample Management

Reports to: VP, Translational Medicine

Employment Type:  Full-Time

FLSA Status:  Exempt

 

POSITION OBJECTIVES:

This position is responsible for managing and maintaining the sample management infrastructure and managing sample shipments on a set timeline.

Work will include but is not limited to overseeing daily operations of 3rd party vendors, preparing for internal and regulated audits, creating work instructions and operating procedures (internal and external), and executing sample compliance initiatives as required by regulatory authorities.

This individual will manage operational and logistical aspects of patient sample shipments for global clinical trials, vendor contracting, sample inventory management, and sample disbursement to third party vendors.

 

POSITION ACCOUNTABILITIES:

  • Manage and prioritize daily workflow activities of 3rd party vendor supporting sampling business processes. This includes establishing performance metrics and enforcing accountability of current business rules. Also includes oversight of outsourced project work and ongoing services that require samples.
  • Manage global and local shipments of patient serum and tissue 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 and work closely with QA group to promote company compliance.
  • Manage samples from multiple clinical trials, technology and software deployments, improvements, and maintenance for all sample management systems.
  • Take lead role in sample inventory reconciliation, returns, discrepancies, lost in transit shipments and closeouts. Work closely with central repository to manage inventory in a timely fashion.
  • Represent sample operations at stakeholder meetings for ongoing and prospective projects to establish and influence project strategies and deliverables related to samples.
  • Manage milestones and timelines across projects, analyze and efficiently communicate project risks and issues as necessary. Proactively 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 timely sample reporting and on-demand support for internal and external parties.

 

EDUCATION, PREFERRED COMPETENCIES AND SKILLS:

  • Bachelor’s degree required
  • Minimum five years pharmaceutical or healthcare industry experience with minimum 3 years clinical experience preferred
  • 3 + years working in sample operations required
  • 2 + years of project management experience preferred
  • Experience with international import/export regulations for biologic materials
  • Extensive knowledge with Microsoft Office applications is a must (Project, Excel, PowerPoint, Access and Word)
  • Organization and time management skills required
  • Must possess strong attention to detail and analytical skills
  • Proven record of being highly detail oriented
  • Excellent references required (minimum 3 – could be managers or subordinates)
  • Excellent oral and written communication skills required.
  • 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.
  • Ability to work remotely but expect global time zones to impact meeting schedules and day to day activities.

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.

 

 

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