Reporting to the CEO, the Vice President, Clinical Operations will provide strategic oversight for all clinical operations activities at Rho.
Serving as a point of escalation for clinical operations and clinical project team issues.
Mentoring, developing, and training clinical personnel and teams.
Providing leadership in the area of clinical operations, including supporting the development of sound enrollment/subject recruitment plans and site feasibility approaches, assisting with clinical research associate challenges, and facilitating the resolution of investigator site issues.
Collaborating effectively across clinical research disciplines including statistics, data management, interactive response systems, investigational product management, regulatory, medical writing, etc.
Growing Rho’s full-service business through networking, leading proposal strategies, acting as the senior clinical expert in bid defenses, participating in business development activities, and creating clinical content for marketing purposes.
Acting as a visible industry expert in clinical operations, ensuring that industry trends in clinical operations are disseminated in a way that supports incorporation of relevant practices into Rho’s operations.
BS required and minimum of 15 years of bio/pharmaceutical development experience in clinical trial operations; CRO experience strongly preferred
Broad experience in drug/biologics development with expertise in clinical trial conduct from Phase 1 through Phase 3 including IND and NDA/BLA/MAA submissions
Experience in strategic planning of clinical trials
Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication
Expertise in building infrastructure to support clinical research, including recommending policies and procedures, best practices, and impactful process and systems improvements for a growing organization
Demonstrated interest in and ability to mentor and develop personnel
Excellent working knowledge of FDA, EMA & ICH/GCP regulations and guidelines
Ability to work in a team environment, meet deadlines, and prioritize and balance workloads
Ability to motivate individuals and teams
Ability to recognize, anticipate, and analyze complex problems and create successful solutions