Senior Manager, Clinical Affairs

About the Company

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.

Primary Function of Position

As a Senior Manager of Clinical Affairs, this role is responsible for contributing to clinical strategies and overseeing study execution for emerging technologies across various specialties.

Clinical trials in this portfolio may be both in the US and global and include first-human-use and pivotal clinical trials targeted for regulatory submission.

This role will oversee and manage clinical protocols and other key study documents in support of regulatory submissions.

This role will manage clinical publications and evidence dissemination strategy, oversee and manage communications with clinical trial sites, CROs, KOLs, and medical societies.

This role will grow, develop, and manage a team to interface and support all clinical requirements of the company with the applicable guidelines and regulations.

This role will foresee challenges and develop critical concepts and methodologies to overcome those.

As a functional manager, this role will also lead a team of clinical operations personnel, such as clinical study managers and clinical research associates, and play a key role in their development.

As a key cross-functional constituent, this employee will work closely with functions across the organization: Regulatory Affairs, R&D, Program Management Office (PMO), Clinical Research Engineering (CRE), Clinical Research Managers, Global Access Value Economics (GAVE), Global Public Affairs (GPA), Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies to meet business objectives.

Roles and Responsibilities

• Play a key role in the development of the company’s strategy for clinical studies to meet business goals and objectives.
• Collaborate with internal stakeholders and KOLs to develop and review study concepts, protocol, and study outlines, subsequently driving identified initiatives.
• Act as a key strategic partner to Regulatory Affairs to support regulatory approval of new products and contribute to clinical sections of regulatory submissions.
• Responsible for managing resource and study budget to ensure clinical studies are conducted on schedule and within budget while ensuring high quality and compliance.
• Build strong and sustaining relationships with investigational sites and investigators for ongoing and future studies.
• Work closely with data management to provide guidance on development of case report form (CRF) and data cleaning to ensure collection of high-quality data.
• Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation, and synthesis in order to develop Clinical Study Report and/or support development of scientific publications.
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement initiatives.
• Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations.
• Provide functional manager leadership to direct reports and provide ongoing guidance for the assigned team members in their internal/external communication and support direct reports in consistently achieving their goals and objectives.
• Set and hold individual and team accountable for high standards of competencies and overall performance.
• Effectively distill complexity and provide clear and actionable direction and information, help the team prioritize, and solve complex problems that enable the team to make significant progress.
• Develop talent, build a highly capable and effective team of clinical study managers (CSM) and clinical research associates (CRA) to efficiently manage clinical studies.

Requirements

• Minimum Education: Bachelor’s or Master's degree in a scientific field, MD, or PhD with 12+ years of professional experience.
• Minimum of 5 years of experience independently managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and closeout).
• Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team.
• Proven track record of strong cross-functional and key opinion leader management.
• Strong experience with clinical study resource and budget management.
• Strong experience supporting development of scientific and regulatory strategy for clinical studies.
• Strong experience in developing study protocol and other study documents, conducting literature review, and writing clinical sections for regulatory submission.
• Strong knowledge of 21 CFR part 812, Good Clinical Practice, ISO14155, and other regulations/guidelines.
• Basic understanding of statistics, statistical methods, and design of experiment.
• Must be able to travel up to 30% to 40%.
• Strong communication, presentation, and interpersonal skills with high attention to detail and organization.
• Results-driven attitude and strong problem-solving skills, consistently showing dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary.

Preferred Qualifications (Nice to Have)

• At least 3-5 years of supervisory experience is preferred.
• Previous experience supporting internal and external audit on clinical studies is preferred.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Comfortable in a hospital environment, with experience working with nurses and surgeons.
• Existing or previous experience/familiarity with surgery/surgical technology is preferred.

Additional Information

Due to the nature of our business and the role, 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.

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.

Category

Healthcare