Senior Director, Clinical Operations, Global

Job Description

This role reports directly to the Global Head of Clinical Research and collaborates closely with the MSA leadership team to provide strategic leadership and direction for the clinical operations team including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across global business unit portfolios.

The individual is a critical member of Clinical Affairs leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the global business units, and within the broader Olympus organization, as appropriate. 

Job Duties

• Provide strategic leadership and direction to the Global Clinical Operations team including project management, clinical monitoring, site management, data management and statistics.
• Oversee end-to-end operational delivery of global clinical trials, including timelines, quality, budget adherence, enrollment performance, and risk mitigation.
• Oversee investigator initiated and collaborative research programs, ensuring that projects are completed according to the contracted timelines and project deliverables are received.
• Leads strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans.
• Align with Global Clinical Leads to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
• Establish and manage processes for regular communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
• Ensure robust study oversight plans, monitoring strategies, data management strategies and statistical methods are implemented consistently across programs.
• Develop and implement processes and procedures to optimize clinical trial operations to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.  
• Strategically develop competencies within the Global Clinical Operations team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of continuous learning and professional development.
• Identify opportunities for process improvement and implement best practices to enhance the efficiency and effectiveness of clinical trial operations.
• In close collaboration with Clinical Quality Assurance, supports the development and maintenance of Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations.
• Partner with Clinical Quality Assurance to prepare for and support regulatory agency inspections and sponsor audits.
• Develops and implement an outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).
• Establish and oversees activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools.
• Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Global Head of Clinical Affairs.
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field.
• Minimum of 15 years device/pharmaceutical industry experience in Clinical Operations, with direct strategic experience in clinical study management for pre and post-market trials. Multiphase experience highly desirable.
• Direct experience managing clinical operations teams, including data management and statistics. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Strong budget and forecasting expertise. Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
• Domestic and international travel up to 10%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
• Scheduling flexibility to commit to a global weekly schedule (Tuesday – Wednesday – Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.

Preferred: 

• MA/MS or PhD degree in life sciences or related field.
• Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP).