Immunocell Therapeutics Inc

Direct the development of clinical strategies and plans.

· Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health

Authorities.

· Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial

results.

Serve as global medical monitor for trials in various phases of development, including Phase 1 safety, dose and signal finding, Phase 2, and Phase 3 registration trials. Lead the development, implementation, and successful execution of clinical and medical operations. Review and approve all clinical procedures, clinical protocols, quality requirements as well as audit and review decisions to ensure their alignment with best practices and with overall strategic goals. Meet with licensing authorities as required and accompanies/assists them throughout inspection or survey activity. Engage with clinical research organizations for implementation of clinical trial site studies Prepare and lead IND submissions interacting and coordinating with CMC and R&D teams

· Lead interactions with academic thought leaders, investigators, cooperative groups, and other

clinical stakeholders.

· Provide clinical support and work with other members of the management team to develop

and communicate the overall corporate strategy.

· Represent the Company and its programs to external audiences, including the investment,

medical and regulatory communities, as well as pharmaceutical or biotechnology industry

collaborators/partners.

Qualifications

· Preferred MD with Board Certification in oncology

· Preferred minimum 10-15 years’ experience in clinical practice treating patients and/or pharmaceutical biotechnology industry experience working on investigational new drugs.

· Multiple years of clinical trial management/operations experience

· A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings.

Knowledge, Skills, and Abilities

· Knowledge of relevant FDA regulations and guidelines as well as those of the EUA and other

health authorities; experience in interactions with regulatory personnel

· Experience with, or strong knowledge of oncology drug development.

· Experience in translational medicine, clinical pharmacology, and early-stage development

· Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines.

· Must have a thorough knowledge of clinical research concepts, practices, and FDA/EUA guidelines

· Possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community.

· Must have excellent leadership and interpersonal skills and have proven skills as an effective team player who can engender credibility and confidence within and outside the company

· Must be science- and data-driven.

· Must have a results-oriented work ethic and a positive, can-do attitude. Effective leadership,

people management, communication skills and a team builder management style are essential;

must be willing and able to be “hands on”.

· Must have the highest of personal values and ethical standards.