Associate Director, Clinical Operations
Full time position

Company Summary


Axovant develops transformative gene therapies for patients with life-altering neurologic conditions.

 

Our mission is to identify, develop, and bring to market high-impact therapies that have the potential to improve the lives of patients with neurological disorders. Our team is made up of leading scientific experts who are passionate about treating neurological conditions and easing the burden of these life-changing disorders for both patients and caregivers. Our team is motivated by the promise of novel drug development and is driven to find more efficient and effective ways to conduct scientific and clinical evaluations that rapidly deliver impactful medicines to patients in need.

 

Our leadership team has a track record bringing innovative new neurotherapeutic treatments to a global market, and along with our seasoned board of directors, is fully committed to the responsible pursuit of transformative therapies for some of the world's most difficult conditions.

 

Overall Summary

The Associate Director, Clinical Operations is accountable for the implementation, management and reporting of assigned clinical trials.  This may include multiple trials within a compound.  In this role, she/he will lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP) and in accordance with the International Conference of Harmonization (ICH) Guidelines. The AD is a key member of the clinical study team, working closely with the Clinical Lead and all functional study team members.  Is accountable for supporting all aspects of assigned study execution, including where applicable, CRO selection, study plan design, execution, study start-up, CRO and vendor management and performance, study budget and timelines. Develops all study plans in collaboration with the CRO and other vendors. Manages all aspects of clinical operational plan with the support of senior Clinical Operations team. Responsible for managing full scope of study or studies in a program

Primary Responsibilities
 
  • Ensure successful completion of clinical studies that are on time and within budget. Works with the Director, Clinical Operations to ensure all needed aspects of clinical operations are identified (vendors, resources, contracts, budgets, etc.) and planned in timely manner. Generates contingency plans where necessary, proactively identify potential issues/risks and mitigate, keeping manager informed.  Oversee the coordination of Investigator Meetings and necessary training of internal team and CRO study team staff.  May require support of Director, Clinical Operations to drive these tasks.

  • Manage and monitor performance of all CROs and vendors to ensure successful completion of program in alignment with timelines and budget.  Escalate potential variances from the timeline/budget real time and proactively to the Director, Clinical Operations to manage changes to scope.

  • Has input into estimated study budget, and supports RFI/RFP process for studies/programs.  Partners with Finance to manage forecasts and actual spends against the study budget on an ongoing basis.

  • Manage and report on performance metrics for the larger team/senior Clinical Operations team to ensure that trials/development program plans are on target.

  • Review clinical data and monitoring metrics to identify trends.

  • Develop risk and mitigation plans as necessary.

  • Track actual vs. expected activity and spend to assess progress.

  • Work with Clinical Supplies colleagues to develop supply/resupply plans and forecasts.  Participate in drug dispensing specification development, technology builds and testing (IxRS) in accordance with the requirements of the protocol.  Review and approve clinical supply and dispensing design and drug labels.

  • Review and contribute to key study documents including protocols, case report forms (CRFs) and Informed Consent templates. Liaise with CRO on regulatory authority and ethics committee requirements and questions.

  • Provide direct line management and support to more junior members of the operations team:  Clinical Trial Manager, Clinical Trial Associate/In-house CRA. 

  • Collaborate with other matrixed resources across the study team on activities and issues:  Data Management, Programming, Biometrics, Safety/PVG, Clinical Research Liaisons, Clinical, Project Management, Clinical Supplies/CMC.

  • Other responsibilities may include development of departmental processes and tools.

Requirements
 
  • Education: 

    • Bachelor’s degree in Life Sciences, Pharmacy or Life Sciences. Advanced degree preferred.

  • Experience (e.g. Jobs, supervisory, industry, international, etc…): 

    • 5+ years of direct experience managing studies at a sponsor or with a CRO is required.  The Director must be able to work collaboratively with others both internally and externally.  1+ years of oversight of team and/or direct oversight of Operations team members.

  • Specialized knowledge, Licenses, etc.: 

    • Good working knowledge of GCP and ICH guidelines

  • Other skills/attributes:

    • Demonstrated alignment with Axovant values and culture

  • Working conditions (ability to travel, lifting….etc.):

    • This position requires approximately 20% travel

 

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)

  • Axovant Gene Therapies LinkedIn
  • Axovant Gene Therapies Twitter
  • Axovant Gene Therapies Facebook

AXOVANT SCIENCES GMBH

Viaduktstrasse 8
4051 Basel
Switzerland