Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Primary Function of Position
The Staff Advanced Clinical Research Manager will be a pivotal person in shaping the clinical strategy and guiding the design of clinical studies and building strategic clinical evidence to drive product innovation and development. This role focuses on leveraging clinical data and insights to inform product design and development, ensuring that new medical technologies are optimized for patient outcomes and regulatory success. The ideal candidate has deep expertise in translating clinical research insights into strategic product recommendations and a solid background in developing clinical protocols for novel technologies.
Essential Job Duties
Clinical Strategy Development
- Develop and head clinical strategies to support product development, ensuring alignment with company goals and regulatory requirements.
- Collaborate with product development and product management teams to translate clinical insights into product design, functionality, and safety improvements.
- Identify key clinical endpoints that will drive product innovation and differentiation in the market.
- Develop and maintain relationships with key opinion leaders, advisory board members, subject matter experts, physicians and other stakeholders to identify clinical needs and translate those needs for user-centric design and development of new platforms, procedures, instruments and accessories. Will include arranging and leading key opinion leader and advisory board meetings.
Protocol Design & Study Execution
- Head study planning, design, protocol development, site selection, budget development and resource allocation for clinical studies for new technology
- Design clinical protocols that provide meaningful data to inform product design and development recommendations.
- Oversee the planning, execution, and management of investigational studies, ensuring studies are designed to capture relevant clinical data to enhance product development in close collaboration with clinical affairs.
- Ensure that clinical protocols are aligned with regulatory requirements and are scientifically rigorous.
Data-Driven Clinical Product Development
- Manage the collection, research, and interpretation of clinical data to provide actionable insights for product development teams.
- Collaborate closely with R&D and engineering teams to incorporate clinical data into design iterations, optimizing product performance and patient outcomes.
- Use clinical study data to identify opportunities for design improvements and to address potential user needs or regulatory challenges early in the development process.
- Ensure all clinical trials meet applicable regulatory requirements and ethical standards.
- Manage clinical data submissions for regulatory filings, ensuring data is robust and aligns with product development strategies.
Cross-Functional Collaboration
- Serve as the clinical research resource on cross-functional teams, providing data-driven recommendations to influence product design, regulatory submissions, and commercialization strategies.
- Work closely with marketing, R&D, and regulatory affairs teams to ensure that clinical data supports product claims and meets market needs.
- Partner with external stakeholders, including key opinion leaders (KOLs) and clinical sites, to gather critical input during product development.
- Directly interface and manage CROs.
Data Analysis & Reporting
- Head the examination of clinical trial data, translating findings into strategic insights that directly inform product design and development.
- Present clinical research findings to internal stakeholders, ensuring data-driven decision-making across the organization.
- Contribute to scientific publications and presentations that communicate key findings from investigational studies to the broader medical community.
Leadership & Mentorship
- Provide leadership to junior clinical staff, fostering a collaborative environment where clinical data is a key driver of product development.
- Manage cross-functional clinical study teams, ensuring alignment on goals, timelines, and key deliverables.
Qualifications
Required Skills and Experience
- At least 10 or more years of relevant clinical / medical / scientific work experience, including leadership functions (i.e. leading or mentoring teams, non-managerial leadership experiences) is required with at least 6 years of experience in medical devices
- Minimum of B.A. or B.S. in Mechanical Engineering, Biomedical Engineering, Biology/Chemistry or similar
- Direct experience in clinical research and/or development is required
- Develop solid commercial and KOL partnerships to inform a value-driven portfolio narrative
- Excellent communication and presentation skills, including experience presenting to senior management and customers.
- Self-starter with ability to take leadership in a fast-paced environment.
- Able to prioritize and smoothly manage multiple tasks.
- Agility to pivot focus to meet evolving sales and customer needs.
- Proven ability to work across disparate parts of an organization to deliver results.
- Well versed in MS Office Suite, Tableau, SFDC and digital marketing tools.
- Ability to work in surgical labs and hospital patient care areas is required.
- Ability to travel 30%. Some international travel may be required.
- The position is located at Intuitive Headquarters in Sunnyvale, California.
Required Education and Training
- At least 10 or more years of relevant clinical / scientific work experience, including leadership functions (i.e. leading or mentoring teams, non-managerial leadership experiences) is required with at least 6 years of experience in medical devices
- Minimum of B.S. in Mechanical Engineering, Biomedical Engineering, Biology/Chemistry or similar
Working Conditions
- Ability to work in surgical labs and hospital patient care areas is required.
- Ability to travel 30%. Some international travel will be required.
- The position is located at Intuitive Headquarters in Sunnyvale, California.
Preferred Skills and Experience
- Masters degree in life science, engineering or MBA preferred.
- M.D., D.O., PhD, MBA, a plus.
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.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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 salary ranges are listed.
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.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
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.
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 salary ranges are listed.
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