Senior Director, Clinical Operations
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.
The Senior Director, Clinical Operations is accountable for the leadership, strategic planning, oversight, execution of clinical operations and the management of staff responsible for our gene therapy products. The individual must have the ability to work independently and also as an effective and engaged team member in a dynamic, fast-paced environment.
These may include but are not limited to:
• Build out and oversee the Clinical Operations function, processes and all activities related to execution of clinical studies and programs in accordance with regulatory guidelines
• Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas
• Recruit, motivate and provide oversight for all in-house clinical operations and external department staff and resources associated within clinical operations, CRO’s and vendors
• Direct the successful execution of all clinical trials, programs, timelines and clinical milestones
• Identify and resolve clinical operations issues related to data management, monitoring, timelines, drug distribution, safety assessment, regulatory compliance, and timely review of trial master files, etc.
• Manage all budgets, contracts, agreements, vendor payments and processes to conduct clinical trial programs in an effective manner.
• Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, BLA, etc.
• Perform other duties as assigned.
• BS in a scientific discipline with 10+ years of Clinical Operations line management experience (an equivalent combination of education and experience may be considered). MS, PharmD or PhD is preferred.
• Extensive background in pharmaceutical and biotech clinical research and development. Experience with cell or gene therapy clinical programs is highly desirable
• Proven history of strategic drug development, demonstrated through comprehensive clinical trial design and execution and prior regulatory accomplishments (NDAs/INDs).
• Proven experience hiring, leading clinical operations teams and overseeing their career growth skills
• Experience managing a rapidly changing organization and integrating new personnel is essential, as well as, ability to evaluate and resolve complex problems
• Demonstrated experience in CRO and vendor management to support global clinical trials, including excellent senior leadership, project management, budgeting, and negotiation skills, required
• Strong knowledge of FDA/EMEA regulations and GCP/ICH guidelines regarding clinical trial management.
• Excellent verbal and written communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff
• Travel may be required up to 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:
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 email@example.com. A member of the Human Resources team will contact you if we require the services your company offers.