Responsibilities:

• Providing operational expertise and strategic input to the development of Clinical Development Plans (CDP) supporting the overall clinical strategy for assigned clinical program(s); may lead some trial management activities within assigned program as well.
• Providing program-level sponsor oversight of CRO and 3rd party vendors to ensure the effective execution of the clinical studies on time, with high quality (e.g., inspection ready) and within agreed budget.
• Collaborating with cross-functional counterparts to oversee the performance for all activities assigned to our CROs and vendors, including escalation of issues when necessary.
• Clinical program budget planning and external spend related to clinical program execution. Working closely with CROs and vendors, Program Management and Finance to ensure that budgets, enrollment, and forecasts are accurate.
• Reviewing and providing expert clinical operations input into clinical documents including Investigator Brochures, Investigational New Drug Applications (INDs) and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis and protocols, clinical study reports, applicable sections of the New Drug Application (NDA) and/or Marketing Authorization Application (MAA), updates to IND and NDA documents, DSURs and other safety reports; may be responsible for the management of clinical document creation or updates.
• Providing expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as appropriate.
• Functional leadership which may include line management, providing input for issue resolution and leading and/or support functional strategic initiatives and process improvement.

Knowledge and Skills:

• Bachelors Degree or international equivalent required, Life Sciences preferred.
• 10 years experience in pharmaceutical industry and/or clinical research organization, including clinical study/project management/clinical trial management.
• Experience of managing oncology clinical programs through phase 1-4.
• Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
• Extensive experience managing complex protocols, CROs, budgets, and timelines
• Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
• Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
• Ability to competently manage multiple competing priorities, adapting as needs change. Must be comfortable working in a fast-paced environment.
• Demonstrated excellence in program management, including scenario assessment, risk assessment, budget management, and contingency planning
• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
• Strong communication skills and ability to work with cross-functional study teams
• Strong organizational skills, sufficient to multi-task in a fast-paced environment with changing priorities
• Excellent written and oral communication skills, including the ability to effectively communicate statistical concepts in a clear and concise manner.
• Ability to work independently and act with initiative to address issues

PRECISION LIFE SCIENCES