Director, External Research Programs

Working Location

Massachusetts, Westborough

Field

This role is responsible for driving the successful execution of Olympus’s External Research Program—including investigator‑initiated trials, collaborative research, and real‑world evidence projects—and for leading the development and optimization of scalable processes that support the creation of evidence generation strategies. The individual oversees a team of clinical scientists and ensures that external research activities are executed with scientific rigor and operational excellence while also establishing and refining the infrastructure needed to enable consistent, high‑quality evidence planning across the organization.

This position requires an inspiring leader with a deep understanding of clinical research, external collaborations, and real‑world evidence generation, who thrives in a dynamic and cross‑functional environment.

• Manage execution of Olympus’s External Research Program, ensuring studies are strategically designed to align with business priorities, efficiently run, and scientifically impactful.
• Lead and mentor a team of clinical scientists supporting external research and evidence generation activities; foster a collaborative and process‑driven culture that emphasizes scientific rigor, accountability, quality, and efficiency.
• Provide guidance to clinical scientists on strategic elements of evidence generation strategy development and clinical trial design (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting).
• Develop, implement, and continuously refine processes and tools for developing/managing evidence generation strategies and externally sponsored research.
• Oversee process for review and approval of external research proposals, including intake, scientific and operational review, contracting, tracking, and deliverables.
• Partner with cross‑functional teams including Clinical Research leadership, legal, compliance, medical, and finance to facilitate seamless study start‑up, execution, and closure.
• Monitor portfolio‑level metrics and provide reporting to leadership on program status, bottlenecks, and continuous improvement opportunities.
• Participate in strategic and operating planning activities in partnership with the Global Clinical Leads, translating corporate and divisional initiatives into operational plans.
• Present updates on the external research program to internal and external stakeholders; support publication strategies.
• Ensure studies conducted under the external research program framework comply with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Perform other duties as assigned.

Required:

• BA/BS degree in life sciences or related field.
• Minimum of 10 years medical device industry experience post‑degree, preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry.
• Minimum of 5 years of direct people management experience.
• Experience leading externally sponsored research programs and developing evidence generation strategies that include investigator‑initiated trials, collaborative research and real‑world evidence.
• Demonstrated track record of developing and implementing operational processes to support external research programs across multiple geographies.
• Strong cross‑functional collaboration experience, including working with Legal, Compliance, Regulatory, Medical Affairs, and Clinical Operations.
• Familiarity with relevant regulations and standards (e.g., GCP, GDPR, Sunshine Act, clinical trial transparency, research compliance).
• Experience with research governance systems or platforms for intake, study tracking, and document management.
• 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.
• Strong project and portfolio management skills, including use of tools for timelines, milestones, and performance metrics.
• Excellent written and…