Vp Of Clinical Operations

– VP of Clinical Operations

Reports to: Chief Strategy Officer

Location: Remote – preference to be given to CA-based applicants. Travel to Irvine, CA, and potentially other clinical trial site locations in the United States is expected during initiation and execution stages of clinical studies.

Responsibilities:

• Coordinate with CMO on safety of all ongoing and planned clinical trials
• In accordance with the Clinical Development Plan, plan and oversee execution of clinical trials in conjunction with Chief Medical Officer (CMO), external Clinical Research Organization (CRO), investigators and clinical site study coordinators, as well as all other clinical operations personnel internal/external to jCyte
• Manage required clinical data on clinicaltrials.gov and support the regulatory team on clinical components of regulatory filings
• Assist in planning, design, and outsource (as necessary) of non-clinical safety studies in support of the Clinical Development Plan
• As appropriate, conduct meetings with Investigators, Clinical/Scientific Advisory Boards, IDMC members, and Key Opinion Leaders
• Coordinate with Chief Development Officer (CDO) and CMO, as well as other applicable internal/external personnel, on the design of clinical trials
• Manage CRO on oversight of Trial Master File (TMF) activities
• Oversee GCP compliance aspects of clinical operations in conjunction with clinical operations and regulatory teams
• Collaborate with the CMC team on inventory logistics of needed clinical trial supplies
• Coordinate with internal/external support on clinical components of Quality Management System
• Oversee team at jCyte Central Testing facility, with a clear understanding of endpoint assessments and imaging techniques that are critical to clinical outcome measures

Qualifications:

Knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical trials/research

• Strong familiarity with standards on Good Clinical Practices (GCP) and International Conference on Harmonization Guidelines
• Strategic thinker with ability to formulate, develop and execute clinical strategies
• Must be detail focused, especially in time-sensitive environments, and maintain a sense of urgency amongst team to adhere to crucial deadlines
• Excellent scientific written and oral communication skills are required
• Innate flexibility to work in a rapidly growing matrixed environment with a dynamic ability to react to unforeseen circumstances
• Track record of building and managing high-performing team and working collaboratively with clinical development and clinical operations teams
• A proven ability to work highly effectively with multiple teams with different backgrounds and cultures
• Experience with planning, designing and conduction of FDA/EMA/Japan GCP compliant clinical trials
• Ability to maintain a professional relationship with key opinion leaders in the field worldwide; comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints, and data interpretation
• Excellent interpersonal skills with ability to lead, interact with, mentor, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines
• Ophthalmic Therapeutic clinical program experience with retina clinical experience highly desired

Education and experience:

• Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical development
• Experience in representing sponsor regarding clinical matters in front of regulatory agencies
• 5+ years of relevant experience in industry with an MD or PhD
• Experience in working with and managing CROs
• Experience in clinical design, implementation, and execution of Phase 1 to Pivotal Stage clinical studies, with direct leadership of trials that have met timelines, budget, and expected outcomes leading to regulatory success