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

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

Qualifications:

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

Education and experience:

• 5+ years of relevant experience in industry with an MD or PhD
• 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
• 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

 
Qualified candidates should forward their resumes to applicants@jcyte.com.

jCyte is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.