Responsible for appropriate execution and oversight of clinical operational development for several Phase 1-2 clinical trials across various cancer indications and tumor types. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate. As applicable, this position is responsible for the coordination of all activities performed by Study Team Members assigned to her/his program/project of responsibility. As needed, responsibilities may include involvement in / leadership of INDs and other regulatory filings. As applicable, is responsible for the line management and development of all manager(s) assigned to her/his program/project. Supports the development of Human Resources programs which may include performance review and talent management and training requirements. Must have demonstrated capacity to lead with minimal supervision, communicate effectively, think strategically, and drive for results.
Orchestrate clinical operations and clinical development activities to successfully execute the portfolio of clinical trials across multiple compounds and corresponding indications under development.
• Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA and global health authority regulations and guidelines, as well as ICH/GCP guidelines.
• Ensure timely feedback on study deliverables and reporting to senior leadership.
• Develop, amend, and review clinical documents such as protocols, ICFs, Investigator Brochures, clinical reports, and any other documents/plans supporting multiple clinical compounds.
• Develop standards for internal documents such as; protocols, ICFs, safety management plans, etc.
• Proficiency in communications and understanding the clinical management of Advaxis immunotherapies across all ongoing and future trials utilizing Advaxis compounds.
• Oversee the process for Serious Adverse Event Reporting from Sponsored trials, Investigator Initiated Trials and collaborations. Ensure adequate regulatory reporting and external communications per established Safety Agreements/Contracts and in collaboration with cross functional company departments.
• Ensure the Advaxis team operates in a constant state of inspection-readiness. Work with internal quality representatives to ensure quality oversight for all studies.
• Create/oversee the development of departmental SOPs and process documents, as appropriate.
• Drive implementation of new company initiatives in terms of process improvement or new
technology related to clinical research.
• Have key input into resolving issues and issue escalation, as well as decision making for relevant
• Lead and/or actively participate in FDA/Health Authority inspections and internal audits.
• Other duties as assigned.
Minimum of 9-10 years’ experience in the clinical research industry, with at least 6 years’ experience in
clinical trial management (CRO/Sponsor)
• Phase 1-2 clinical trial experience required, Experience of Phase 3 a plus
• Oncology experience is required; immunotherapy experience a plus
• Line management skills and expertise / mentoring and coaching
• Financial forecasting with budgeting and resourcing skills
• Leadership and negotiations skills
• Effective teamwork and teambuilding skills transferable across functional levels
• Strong collaborative, leadership and communication (written and oral) skills
• Excellent organizational skills and attention to detail
• Ability to prioritize competing demands to successfully meet deadlines and project milestones
• Adept at preparation and conduct of Competent Authority inspections and sponsor directed audits
EDUCATION: (Describe the minimum level of education required for this position)
• BA/BS or equivalent degree in life sciences or allied health field or work experience; advanced degree
SPECIALIZED KNOWLEDGE, LICENSES, CERTIFICATIONS: (Describe any additional qualifying knowledge,
licenses or certifications required)
• Knowledge of clinical study guidelines including FDA, ICH & GCP.
• Good scientific and medical knowledge and experience in clinical development/operations in all phases.
• Skilled in responding to regulatory questions posed by FDA and Competent Authorities.
• Strong computer/technology skills including MS Excel, PowerPoint, and MS Word.