Technical Manager, CDM
Consultant Position

Company Summary

Axovant Gene Therapies seeks a Director of Regulatory Affairs to contribute to the overall success of the company working to develop cures for rare and devastating CNS diseases using novel AAV gene therapy approaches. We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline and late phase clinical development, working in partnership with the development R&D team and CMOs. This position reports into the head of Regulatory Affairs.

 

The candidate must be able to interpret biologic/ATMP regulations as they apply to given phases of drug development including preclinical, clinical and commercial.  This is an exciting team-building, hands-on leadership role within the Axovant team. The position will be based in the US in the New York City headquarters.   Remote candidates are also considered, preferably EST time zone.

Summary

The Technical Manager, CDM will design, implement, document, manage, and oversee both routine and complex reports used to perform clinical data review and cleaning, including but not limited to protocol compliance checks, safety data trend analyses, and operational metrics.  Reports can be created using a variety of tools and programming languages including but not limited to SAS, JReview, Python, R, or SQL.  This role is intended to actively communicate with clinical trial team (CTT) members regarding data reporting requirements and issues and will serve as a technical specialist to troubleshoot any issues for data reporting and data review and cleaning platforms across all of clinical development.

Primary Responsibilities
  • Develop, test, implement, and document processes

  • Design, test, and maintain reports used for data cleaning, data reconciliation, and data visualization across all clinical development functions

  • Participate in the development, maintenance and improvement of standard reports across all clinical development functions

  • Develop process for automation of generating data cleaning and metrics reports per study needs

  • Provide technical support and expertise for existing data reporting tools

  • Validate new data reports and reporting tools as necessary

  • Support the testing of the programs developed by other CTT members

  • Research new innovations in data management and identify opportunities for their application

  • Assist in selection and implementation of new data management systems and tools (if applicable)

  • Act as technical lead in discussions with software vendors/developers

  • Working closely with study leads from biometrics, clinical research and clinical operations to ensure departmental and corporate clinical trial data management objectives are met.

  • Ensure accuracy, completeness, and consistency of clinical trial data by managing DM staff efforts involving data collection, data cleaning, final quality review activities and archiving study databases and supporting documents, including oversight of the preparation of ad hoc listings and review of reports for data review and cleaning protocol or BIQR. Overseeing the work of the DM staff in the management of CRO data management activities to ensure acceptable quality of DM deliverables.

Requirements
 
  • MS (preferred) or BA/BS with equivalent experience

  • Minimum of 3 years pharmaceutical industry experience

  • Must have SAS, SQL, Spotfire, J-Review, BOXI, and/or Elluminate experience

  • Strong understanding of drug development process, and familiarity with all phases of clinical trials

  • Extensive knowledge of the clinical data collection process

  • Good understanding of industry best practices and awareness of regulatory requirements (e.g., 21CFRPart11)

  • Good understanding of CDISC data standards (especially CDASH and SDTM)

  • Excellent written and oral communication skills

  • Proven ability to manage multiple projects/tasks at one time

  • Experience dealing with a mix of legacy data and CDISC data

  • Experience with various EDC systems (e.g., Medidata Rave, Inform, or similar system)

  • Familiar with handling multiple vendors and data transfer agreements and external data reconciliation

  • Experience with IVRS/IWRS and electronic clinical outcomes assessments and vendors is a plus

  • Understanding of MedDRA and WHO Drug coding

Additional Characteristics

  • Deeply motivated self-starter with an entrepreneurial spirit

  • Thrives in a quickly changing, fast-paced environment

  • Desire to work in multiple therapeutic areas

  • Unrelenting dedication to delivering quality results

  • Being an integrity role model by visibly and consistently speaking and acting with superior moral values

  • Willing to roll up your sleeves to get the job done

  • Able to work with CRO personnel and gain their trust and respect

  • Willing to travel ~15%

 

This is an exciting time to join the field of gene therapy in general, and to become a part of Axovant Gene Therapies’ fast-growing dedicated team. Axovant Gene Therapies is a publicly traded company (NASDAQ: AXGT). We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

All interested applicants should send a cover letter and resume to: HR@axovant.com

Agencies/Recruiters

 

We maintain a list of approved professional recruiting agencies with which we have signed agreements. Candidates will be considered only when the agency has a signed agreement and Human Resources authorization to present candidates for a specified position(s). Candidates submitted outside of this process are considered unsolicited and will not be considered. Agencies interested in establishing a relationship with Axovant may send company information to careers@axovant.com. A member of the Human Resources team will contact you if we require the services your company offers.

AXOVANT GENE THERAPIES

Eleven Times Square, 33rd Floor
New York, NY 10036
United States

+1-833-AXOVANT (1-833-296-8268)

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AXOVANT SCIENCES GMBH

Viaduktstrasse 8
4051 Basel
Switzerland