VP 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.

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Job Title:  VP Clinical Operations

Reports to:  SVP Clinical Operations and Medical Affairs

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  TBD

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:

  • 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 (preferred)
  • Experience in all phases of clinical trials through marketing submission
  • Successful presenting/defending clinical strategies to FDA and other regulatory agencies

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 Director Biostatistician

Summary of Position:

The successful candidate will be responsible for overseeing all statistical activities associated with Aravive’s clinical studies. The successful candidate will work collaboratively with in-house clinical, non-clinical and data management groups, as well as their external vendor counterparts and statistical programmers, to plan and execute analyses of all types of clinical studies, including clinical pharmacology.

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Job Title:  Senior Director Biostatistician

Employment Type:  Full-Time

Location:  RTP, NC

FLSA Status:  Exempt

Date:  TBD

Key Essential Functions:

  • Provision of timely and scientifically sound statistical expertise to clinical, clinical pharmacology and non-clinical development projects.
  • Interact with members of project teams, clinical scientists, clinical pharmacologist, statistical programmer and data management personnel to establish project timelines, data validation checks and perform statistical analyses.
  • Responsibility for providing statistical expertise in clinical study design and analysis.
  • Collaborate in the preparation and review of protocols, CRF design and clinical study reports.
  • Develop statistical analysis plans, perform exploratory data analysis as necessary and provide data interpretation.
  • Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results.
  • Collaborate with Data Management and Clinical Operations staff to implement guidelines and standards to CROs to ensure quality of deliverables.
  • Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.

Required Skills & Abilities:

  • Excellent oral and written communication skills
  • Excellent organization skills with acute attention to detail
  • Ability to work and multi-task in a fast-paced environment
  • Strong computer skills, including SAS and dashboard systems
  • Current experience in biotech industry

Required Qualifications:

  • PhD or Masters in biostatistics.
  • Minimum of 7 years pharmaceutical industry experience with clinical trials, particularly in study design and analysis.
  • Experience with regulatory submissions is necessary.
  • Experience with CRO management or oversight.

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

SVP /EVP Clinical Development

Summary of Position:

We are seeking an MD with clinical development experience in oncology to lead all of Clinical Development and drive clinical/regulatory strategy and oversee our ongoing clinical studies. The candidate should have a strong drug development background and proven expertise with the design and execution of programs investigating therapeutic biologics. The candidate must have excellent organizational and interpersonal skills, as well as work independently, with the ability to communicate effectively across internal teams and CROS.

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Job Title:  SVP /EVP Clinical Development

Reports to:  CEO

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  TBD

Key Essential Functions:

  • Represent medical in review/development of safety reports, safety events, and safety summaries, analyzing for trends in the data
  • Support and drive as needed the development of publications and posters
  • Provide medical input and oversight on regulatory document preparation
  • Address inquiries from Investigators on eligibility and patient management
  • Organize and deliver relevant training to Medical Affairs Operations / CRO staff
  • Participate in the preparation and review of clinical study reports as assigned
  • Represent the company in due diligence activities
  • Manage regulatory, clinical writing, data management, and clinical operations

Required Skills & Abilities:

  • Strong knowledge of clinical trials and study designs.
  • Medical practice experience, preferably in oncology
  • Excellent oral and written communication skills, ability to work productively in a fast-paced and collaborative team environment
  • Ability to work independently in virtual R&D organization with demonstrated ability to independently design and execute experimental plan
  • Excellent organization skills with acute attention to detail
  • Outstanding medical and scientific writing/editing skills with strong critical thinking and analytical skills.

Required Qualifications:

  • A doctor of medicine degree (MD).
  • Minimum 10 years’ experience in clinical development or medical affairs.
  • Minimum 8 years’ experience in oncology.
  • Travel of up to 20% may be required.

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

Sr. Statistical Programmer – Oncology

Summary of Position:

We are seeking a Sr. Statistical Programmer with extensive SAS programming expertise gained within an oncology clinical drug development program.  This role offers the potential for career growth and additional responsibilities as Aravive expands its clinical development programs. The Sr. Statistical Programmer will ensure programming conducted by a contract research organization (CRO) is consistent with CDISC standards and that analyses, tables, figures and listings align with study protocols and statistical analysis plans.  The Sr. Statistical Programmer will collaborate with Aravive colleagues and develop internal data standards and processes, and ad hoc analyses and reports.  The Sr. Statistical Programmer will also work with data managers to ensure the quality of the data and audit trails.

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Job Title: Sr. Statistical Programmer – Oncology

Employment Type: Full-Time

FLSA Status: Exempt

Date: TBD

Key Essential Functions:

  • Work cooperatively with study team members including but not limited to biostatisticians, CRO statistical programmers, data managers, and clinicians.
  • Oversee the CRO statistical programmers
  • Oversee the development of specifications for converting raw data to SDTM and ADaM datasets, and ensuring the datasets are programmed according to approved specifications.
  • Review clinical study protocols with regard to statistical programming responsibilities
  • Review and provide input to Statistical Analysis Plans and Statistical Programming Plans
  • Review and provide input to Case Report Forms
  • Ensure tables, figures and listings are programmed according to approved specifications.
  • Review accuracy of results produced for clinical study reports
  • Develop and maintain ADaM and STDM specifications for Aravive clinical studies
  • Inform management of the status of statistical programming deliverables and issues
  • Produce ad hoc data analyses and reports
  • Contribute to standards and process improvements

Required Skills & Abilities:

  • Expertise in CDISC standards and industry best practices for oncology studies
  • Advanced SAS programming skills; competent with macro programming
  • Excellent understanding of relational databases such as EDC systems
  • Ability to create CDISC compliant datasets from raw data
  • Understanding of requirements for regulatory submissions
  • Advanced knowledge of inferential statistics is preferred.
  • Working knowledge of regulatory agency requirements (e.g., FDA, EMA) and guidance documents
  • Experience handling external data such as lab data, PK data, imaging data, etc.
  • Working knowledge of MedDRA
  • Excellent oral and written communication skills, ability to work productively in a fast-paced and collaborative team environment
  • Ability to work independently in virtual R&D organization with demonstrated ability to independently design and execute experimental plan.
  • Excellent organization skills with acute attention to detail

Required Qualifications:

  • At least five years of oncology industry experience and expertise as a SAS statistical programmer for Phase 1, 2 and 3 studies. Lead programmer experience is expected
  • Demonstration of leadership skills and abilities
  • Experience guiding the development of clinical trial databases
  • Experience leading regulatory submissions

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