This position will report to and work under the supervision of the Chief Medical Officer.
The VP/Head of Global Clinical Operations will be a key leader with responsibility for executive oversight and overall management of all Rakuten Aspyrian clinical study programs and overall trial conduct and be a executive member of the product development team.
This position will work closely with the Chief Medical Officer, the Clinical Operations Team, Medical Directors, Field Trainers, Data Management, Biostatistics, Clinical Supplies Management, Quality Assurance, Clinical Development, Medical Writing, and Program Management to ensure operational implementation of clinical trials to maximize efficiency, contain execution costs, and meet timelines.
Key areas responsibilities will include coordinating and leading the clinical operations functions, study planning, financial oversight, vendor management, managing trial and program timelines and ensuring GCP compliance and providing expertise and strategic guidance as an executive member of the product development team.
The ideal candidate will have a minimum of 20 years of direct experience overseeing all phases of global clinical trials, performing effectively as a member of the senior management team, managing cross-functional teams and managing CRO/vendor relationships. Global phase 3 oncology trial experience is highly preferred. Combination drug/device experience is a plus.
Key Duties and Responsibilities
- Provide executive oversight of current and future global clinical programs for various oncology indications from Phase 1 to NDA/BLA approval
- Provide direct oversight and management of operations and personnel involved in clinical operations, data management, biometrics, medical writing and other functional groups as assigned
- Provide operational and clinical expertise and strategic insights to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development
- Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
- Review master service agreements, statements of work, and quality agreements relating to clinical operations
- Provide oversight of global CROs and vendors from identification to selection to close of contracts
- Participate in developing and providing input to protocols, annual safety reports, Investigator Brochures, clinical study reports, publications/presentations and regulatory submissions
- Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices
- Plan clinical headcount and hiring needs to meet program workload demands
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs
- Lead initiatives to build clinical department infrastructure
- In collaboration with QA, ensure that clinical trials are conducted in compliance with applicable regulatory requirements and inspection-ready
- Represent/advocate for clinical operations needs/resources at a senior management level
- Other duties as assignedDesired Education, Skills and Experience
- Degree in the life sciences or related field
- At least 20 years of clinical operations experience in a pharmaceutical/biotech environment, including global experience. At least 5 years within a similar role as listed in this job description.
- Global clinical trial management experience (specifically Phase 3 oncology) highly preferred
- Experience managing CROs and vendors throughout entire clinical operations life cycle
- Proven success participating in cross-departmental (senior management, regulatory, QA, CMC, program management, finance, business development, pharmacovigilance, medical affairs, clinical development, medical writing) clinical strategy, planning and implementation activities
- Proven success in leading and coordinating cross-functional clinical operations teams (e.g., clinical operations, data management, biostats, clinical supply chain)
- Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience preferred
- Excellent working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices
- Collaborative and team-oriented
- Demonstrates strong problem-solving, communication, and leadership skills
- Demonstrates strong organizational, project management, and soft skills
- Previous experience with combination drug-device studies, a plus
- Willing to travel to support clinical and corporate activities
Location: San Mateo, CA