Research Science Management

About the role

Primary Function of Position

The purpose of this job function is to serve as a Scientific Research Program Manager (SRPM) in the Digital Business Unit to support research projects, within the United States and across the world, to demonstrate the performance and impact of Intuitive Surgical's Digital products and services.

This role has responsibility to oversee initiation, progress, and conduct of evidence-generation studies to include those conducted by internal scientific teams as well as Intuitive-sponsored studies and studies done in collaboration with external research partners. The SRPM serves as a contact to all parties involved in projects, internal and external.

Roles & Responsibilities

• Manage and execute a portfolio of internal and external collaborative research studies and evidence-generation activities for Intuitive Surgical's Digital products and services, with or without the assistance of research coordinator(s)
• Be responsible for the management of the research studies 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 with follow through to ensure a successful outcome
• Work with data management professionals and statisticians as needed for assigned projects
• Maintain study documentation (e.g., correspondence, documentation required by the U.S Code of Federal Regulations (CFR), deviations, budget information)
• Plan and manage the project timelines to ensure research studies are conducted in a timely manner and within the project budget
• Proactively anticipate and communicate concerns, issues, and delays in the project and develops risk assessment and contingency plans
• Prepare project status updates and power point presentations for reporting to internal and external stakeholders for assigned projects
• Prepare reports in support of external and internal steering or advisory committees as needed
• Manage publication development, submission, and response to peer review for related to research studies
• Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and international guidelines)
• Ensure audit readiness of research projects to relevant regulatory and legal standards
• Management of Contract Research Organization (CRO) or independent research service providers (e.g., identification of suitable partner(s), development of contracts or statements of work, and management of stakeholders to ensure project success)
• Facilitate participation in meetings and reporting with adherence with Intuitive Surgical policies
• Review and develop internal processes (e.g., SOPs)
• Build, nurture, and maintain relationships with external research partners and stakeholders, which may include but are not limited to 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 & Requirements

Skills, Experience, Education, & Training

• Bachelor's degree or equivalent in life sciences, medicine, medical sciences, engineering, or computer/data science (required); graduate degree (preferred)
• Experience working in the healthcare technology industry in a clinical affairs or scientific research function with evidence of full project management responsibility for at least three years (required)
• Five years of experience in the management of research, with experience in clinical research management in both academic/hospital and industry settings (preferred)
• Knowledge of applicable clinical research and medical device regulations and guidelines including GCP, ISO-14155, MEDDEV, MDR and Data protection rules (required)
• Protocol and CRF development experience (required)
• Excellent organizational skills with the ability to manage multiple projects with competing priorities (required)
• Ability to manage a minimum of three to five research projects across different surgical disciplines and/or products (required)
• Excellent communication and interpersonal skills with strong negotiation abilities (required)
• Ability to work independently and across teams whilst keeping open communication with key stakeholders (required)
• Strong numerical and literary analytical skills with the ability to assess data and literature
• Experience reviewing data sets to evaluate data quality
• Experience with studies of health information technologies including artificial intelligence is an advantage
• Ability to manage CROs or external consultants
• Ability to manage research coordinators or other research staff in the execution of research studies
• Experience of publishing research (own or in industry capacity) is an advantage
• Excellent problem-solving skills and initiative
• English language required, a second language is an advantage
• Comfortable in a hospital/surgical environment
• Ability to travel from 25% up to 50% of the time

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

Accommodation & Accessibility Notice

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.