Associate Director, Quality Systems

Summary of Position: The successful candidate will be actively involved in helping build the Quality Assurance (QA) systems at Aravive. This individual will have the responsibility for establishing, implementation and management of the quality systems with the primary focus of Electronic Quality Management Systems (EQMS), training, auditing, vendor qualification, quality metrics tracking and reporting. The position will also include working with cross-functional teams to support regulatory filing activities. 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, Quality Systems

Reports to:  Senior Director, Quality Assurance

Employment Type:  Full-Time

FLSA Status:  Exempt

Date:  Fall 2020

  • 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 GXP training program and provide training as required including the annual GCP training.
  • Manage and maintain the vendor qualification program and GXP contract service provider audits.
  • Maintain quality agreements with contract service providers/vendors
  • Oversee the deviation, CAPA, change control, investigation and non-conformance programs to ensure compliance with internal SOP and regulatory authority requirements.
  • Develop, track and trend quality metrics.
  • Interact with clinical and regulatory departments in support of Regulatory Submission activities.
  • Participate in the review of regulatory submission documents.
  • May perform internal and external audits.
  • Collaborate with cross functional teams on FDA and other regulatory authority inspections, including inspection preparation, hosting and responding to observations.
  • 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 within technical operation, manufacturing and/or QA functions.
  • Prior experience in implementation and management of Quality Management System is required.
  • Experience with biological products in Oncology preferred
  • Strong technical writing skills.
  • Strong knowledge of cGMP/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

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.

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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

Director/Senior Director, Medical Writing

Summary of Position:

The successful candidate will be a strong scientist with biopharmaceutical experience who can collaborate with members of cross-functional teams to prepare high-quality protocols, protocol amendments, investigator brochures, synopses, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines. 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:  Director/Senior Director, Medical Writing

Reports to:  SVP Data Sciences

Employment Type:  Full-Time

Location:  US East Coast (NC preferred)

FLSA Status:  Exempt

Date:  Fall, 2020

Key Essential Functions:

  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Manages the corporate EndNote 9 shared bibliographic library
  • Manages all aspects of outsourced or internal CSR production and ensures project delivery
  • Partners with other clinical team leaders including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
  • Works closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • 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 knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
  • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details
  • 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 scientific or medical 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 computer skills, including use of EndNote 9 within MS Word for references management

Required Qualifications:

  • Bachelor’s degree +8 years, Master’s Degree + 5 years, Doctoral Degree + 2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred
  • Title will be commensurate with experience
  • Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence, and/or NDAs/BLAs and peer-reviewed journal articles

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