Senior Director, Clinical Operations, Global

Req ID: 10148 Working Location: Nationwide; Pennsylvania, Center Valley Workplace Flexibility: Remote For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​ ​ ​ Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives. ​ Our five Core Values empower us to achieve Our Purpose: Patient Focus, Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: https://www.olympusamerica.com/careers . 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). Why join Olympus? We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture. Equitable Offerings you can count on: Competitive salaries, annual bonus and 401(k)* with company match Comprehensive medical, dental, vision coverage effective on start date 24/7 Employee Assistance Program Free live and on-demand Wellbeing Programs Generous Paid Vacation and Sick Time Paid Parental Leave and Adoption Assistance* 12 Paid Holidays On-Site Child Daycare, Café, Fitness Center** Connected Culture you can embrace: Work-life integrated culture that supports an employee centric mindset Offers onsite, hybrid and field work environments Paid volunteering and charitable donation/match programs Employee Resource Groups Dedicated Training Resources and Learning & Development Programs Paid Educational Assistance *US Only **Center Valley, PA and Westborough, MA Are you ready to be a part of our team? Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks . The anticipated base pay range for this full-time position is $162,565.00 - $243,847.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual. Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications. At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com . You Belong at Olympus We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [email protected]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787). Let’s realize your potential, together. It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs Job Segment: Manager, Quality Assurance, QA, Document Management, Consulting, Management, Technology, Quality