Director, Clinical Research - URO/GYN/SD

Job Duties

• Develop and lead integrated Evidence Generation Strategies for the URO business aligned with regulatory, HEMA, publication, marketing, and commercial objectives across product lifecycle stages.
• Provide clinical and scientific leadership for URO technologies through strategic evidence planning, cross-functional collaboration, and prioritization of clinical initiatives.
• Lead global clinical research strategy, including oversight of study design, protocol development, endpoint strategy, data interpretation, and evidence dissemination activities.
• Provide strategic direction and scientific oversight to matrixed Clinical Scientists supporting product-level evidence generation and study activities.
• Partner with Clinical Operations leadership to support successful execution of clinical studies while maintaining scientific oversight throughout the study lifecycle.
• Support strategic partnerships, distribution opportunities, acquisitions, and business development initiatives through clinical and scientific leadership.
• Monitor evolving clinical, regulatory, reimbursement, and governance landscapes and translate insights into actionable clinical and business strategies.
• Serve as a scientific ambassador for Olympus through engagement with KOLs, advisory boards, investigator networks, scientific societies, and global congresses.
• Lead publication and scientific communication activities, including manuscripts, conference presentations, publication planning, and evidence dissemination initiatives.
• Oversee investigator initiated trials, collaborative research, and real-world evidence activities, including scientific evaluation, governance, and prioritization aligned with business objectives.
• Provide clinical and scientific review of promotional, advertising, and external communication materials to ensure scientific accuracy and compliance with applicable requirements.
• Contribute to Clinical Research leadership initiatives focused on organizational strategy, infrastructure development, SOPs, best practices, talent development, and operational excellence.

Job Qualifications

Required:

• BS degree in life sciences or related field.
• Minimum of 15 years medical device industry experience preferably in Clinical Research or Medical Affairs within biotech industry (preferably in multiple phases and multiple roles).
• Deep expertise in designing and executing global clinical evidence generation programs, including protocol development, study design, endpoint strategy, clinical study report development, and integrated publication planning to support regulatory, reimbursement, scientific, and commercial objectives.
• Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
• 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.
• 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.
• Flexibility to work across global time zones and collaborate effectively with international teams, including availability to support meetings and business activities outside standard local working hours as needed.
• 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.
• Urology (BPH, stone management) experience.