Global Clinical Lead, Urology

Job Description

The Global Lead of Urology Clinical Affairs reports directly to the Global Head of Clinical Affairs and collaborates closely with the leadership of Clinical Affairs to lead clinical strategy activities and oversee all aspects of clinical studies in support of clinical evidence generation strategies across the Urology business unit portfolio.

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 Urology business unit,  and within the broader Olympus organization, as appropriate. 

Job Duties

• In collaboration with internal and external to MSA stakeholders, contribute to an evidence generation strategy that will drive the clinical evidence strategy for the Urology business unit.
• Oversees all aspects of Clinical Study Management within the Urology business unit, 
• Clinical Study Management includes all activities mandated by 21 CFR 812 or EU-MDR and GCP (ISO-14155:2020) and related to enrolling and following subjects in a clinical study at research sites including documented evidence of compliance.
• Provides critical input into Business Development, R&D, and Urology business unit product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product’s value proposition. In situations entailing substantial clinical risk, they propose reasonable mitigation strategies, which may involve future clinical studies.  
• Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs,  in translating corporate and divisional initiatives into operational plans.
• Develops 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).
• Establishes 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.
• Ensures 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.
• Develops and works to continually improve Clinical Affairs’ infrastructure, including development of SOPs, best practices, and training and workshops. 
• Provides leadership, career development, coaching and mentoring to direct reports as well as developing a succession plan.
• Other duties as assigned.

Job Qualifications

Required:

• BA/BS degree in life sciences or related field
• Minimum of 15 years device/pharmaceutical industry experience preferably in Clinical Affairs/Operations, Medical Affairs within pharma/biotech industry (preferably in multiple phases and multiple roles).
• 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. 
• 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. 
• Domestic and international travel up to 20%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.

Preferred:

• MA/MS or PhD degree in life sciences or related field
• Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)
• Direct people management experience and managing teams.
• Strong budget and forecasting expertise.
• Experience working on Urology studies and programs.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration. 
• Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.