Scientific Research Program Manager

Job Description

Primary Function of Position

The purpose of this role is to serve as a Scientific Research Program Manager (SRPM) for the da Vinci Cardiac Surgery Program. The SRPM, Cardiac surgery will oversee the development of evidence-generation strategy for the Cardiac Surgery Program and support research projects to demonstrate the performance and impact of Intuitive Surgical's da Vinci platforms, products, and services within the United States and globally. This role oversees the initiation, progress, and conduct of evidence-generation studies, including those conducted by internal scientific teams, Intuitive-sponsored studies, and studies conducted in collaboration with external research partners. The SRPM serves as a key contact for internal and external parties involved in assigned projects.

Essential Job Duties

• Collaborate with Cardiac Surgery Program leaders and cross-functional evidence stakeholders to identify evidence gaps, align on evidence 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 research studies across the study lifecycle, including project development, budgeting, investigator selection, analysis of potential participant recruitment, preparation of study-related documents (e.g., protocols, case report forms, informed consents, research agreements), and management of Institutional Review Board and/or Ethics Committee submissions through successful outcome.
• Collaborate with data management professionals and statisticians as needed; maintain required study documentation; and plan and manage project timelines and budgets to support timely execution.
• Proactively identify and communicate project concerns, issues, and delays; develop risk assessments and contingency plans; and prepare project status updates, presentations, and reports for internal and external stakeholders and steering or advisory committees.
• Manage publication development, submission, and responses to peer review related to research studies.
• Ensure compliance with corporate requirements (e.g., SOPs) and applicable regulatory requirements (e.g., GCP and U.S. and international guidelines), and maintain audit readiness to relevant regulatory and legal standards.
• Manage Contract Research Organizations (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 Intuitive Surgical policies; and support review and development of internal research processes (e.g., SOPs).
• Build, nurture, and maintain relationships with external research partners and stakeholders, including surgeon key opinion leaders, operating room staff, hospital and health system administrative and technology leaders, surgical and scientific professional society leaders, and healthcare technology industry partners.

Qualifications

Required Skills and Experience

• 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; industry research management experience preferred.
• 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 a minimum of three to five research projects across different surgical disciplines and/or products.
• Strong communication, interpersonal, and negotiation skills, with the ability to manage work autonomously and collaborate across teams while maintaining open communication with key stakeholders.
• Strong quantitative and literature analysis skills, with the 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 the execution of research studies.
• Strong problem-solving skills and initiative; English-language proficiency required.

Required Education and Training

Bachelor's degree or equivalent in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.

Working Conditions

Work may require presence in hospital and surgical/operating room environments. Ability to travel 25%-50% of the time.

Preferred Skills and Experience

• Graduate degree in life sciences, medicine, medical sciences, engineering, computer science, data science, or a related field.

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