Scientific Research Program Manager

Intuitive•Sunnyvale, CA

About The Position

The Scientific Research Program Manager (SRPM) for the da Vinci Cardiac Surgery Program oversees the development of the program’s evidence-generation strategy and supports research demonstrating the performance and impact of Intuitive Surgical’s da Vinci platforms, products, and services in the United States and globally. The role oversees the initiation, progress, and conduct of evidence-generation studies, including work led by internal scientific teams, Intuitive-sponsored studies, and projects with external research partners. The SRPM serves as a key contact for internal and external parties involved in assigned projects. The role collaborates with program leaders and cross-functional stakeholders to identify evidence gaps, set priorities, and develop plans. It manages research projects throughout their lifecycle, including study development, budgets, investigator selection, participant recruitment analysis, study documents, ethics submissions, timelines, documentation, risk planning, and reporting. The SRPM also manages publications, CROs and other research providers, regulatory and corporate compliance, and relationships with external research partners and stakeholders. Work may require presence in hospital and surgical or operating room environments, and travel of 25%–50% of the time. Intuitive and/or its customers may require proof of vaccination against certain diseases, including COVID-19; details may vary by role.

Requirements

At least five years of experience in an academic setting or healthcare technology industry in a clinical affairs or scientific research function, with evidence of full project management responsibility.
Knowledge of applicable clinical research and medical device regulations and guidelines, including GCP, ISO 14155, MEDDEV, MDR, and data protection requirements.
Experience developing research protocols and case report forms (CRFs).
Strong organizational skills and ability to manage multiple projects with competing priorities, including three to five research projects across different surgical disciplines and/or products.
Strong communication, interpersonal, and negotiation skills, with ability to work autonomously and collaborate across teams while maintaining open communication with stakeholders.
Strong quantitative and literature analysis skills, including ability to assess data and scientific literature and review data sets for data quality.
Ability to manage CROs, external consultants, research coordinators, or other research staff in executing research studies.
Strong problem-solving skills and initiative.
English-language proficiency.
Bachelor’s degree or equivalent in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.
Ability to travel 25%–50% of the time.

Nice To Haves

Industry research management experience.
Graduate degree in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.
Five years of research management experience, including clinical research management in both academic/hospital and industry settings.
Experience with studies of health information technologies, including artificial intelligence.
Experience publishing research in an academic or industry capacity.
Proficiency in a second language.

Responsibilities

Collaborate with Cardiac Surgery Program leaders and cross-functional evidence stakeholders to identify evidence gaps, align on priorities, and develop evidence-generation plans.
Manage and execute a portfolio of internal and external collaborative research studies and evidence-generation activities for Intuitive Surgical’s da Vinci platforms, products, and services, with support from research coordinators as applicable.
Manage studies throughout the lifecycle, including project development, budgeting, investigator selection, participant recruitment analysis, and preparation of protocols, case report forms, informed consents, and research agreements.
Manage Institutional Review Board and/or Ethics Committee submissions through successful outcome.
Collaborate with data management professionals and statisticians as needed; maintain study documentation; and plan and manage timelines and budgets.
Identify and communicate project concerns, issues, and delays; develop risk assessments and contingency plans; and prepare status updates, presentations, and reports for stakeholders and steering or advisory committees.
Manage publication development, submission, and responses to peer review related to research studies.
Ensure compliance with corporate requirements and applicable regulatory requirements, and maintain audit readiness to relevant regulatory and legal standards.
Manage CROs and independent research service providers, including partner identification, contract or statement-of-work development, and stakeholder management.
Facilitate meetings and reporting in accordance with company policies and support review and development of internal research processes such as SOPs.
Build and maintain relationships with external research partners and stakeholders, including surgeon key opinion leaders, operating room staff, hospital and health system leaders, professional society leaders, and healthcare technology industry partners.