Senior Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

1d•$157,800 - $278,400•Hybrid

About The Position

The Senior Manager of Clinical Affairs contributes to clinical strategies and oversees execution of studies for emerging technologies across multiple specialties. The portfolio may include U.S. and global clinical trials, including first-human-use and pivotal trials intended to support regulatory submissions. The role oversees clinical protocols and other study documents, manages clinical publications and evidence dissemination, and coordinates with clinical trial sites, CROs, key opinion leaders, and medical societies. It develops and manages a team that supports the company’s clinical requirements in accordance with applicable guidelines and regulations, anticipates challenges, and develops methods to address them. As a functional manager, the position leads clinical operations personnel, including clinical study managers and clinical research associates, and supports their development. The role works across Regulatory Affairs, R&D, the Program Management Office, Clinical Research Engineering, Clinical Research Managers, Global Access Value Economics, Global Public Affairs, Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies and meet business objectives. It manages study resources and budgets, supports regulatory approval strategies, and helps ensure high-quality, compliant studies are completed on schedule and within budget. This is a purposeful-onsite role requiring onsite attendance for leader-defined events and activities, potentially monthly or annually, with frequency subject to increase based on business need. Travel of up to 30–40% is required. The position is listed as a day shift.

Requirements

Bachelor’s or master’s degree in a scientific field, or an MD or PhD, with 12 or more years of professional experience.
At least 3–5 years of supervisory experience is preferred.
At least 5 years of experience independently managing clinical studies through multiple phases, including pre-IDE, IDE submission, site selection and activation, study execution, data analysis and reporting, and closeout.
Excellent clinical operations and project management skills, with strong experience collaborating with or leading cross-functional teams.
Proven ability to manage cross-functional relationships and key opinion leaders.
Strong experience managing clinical study resources and budgets.
Strong experience supporting clinical study scientific and regulatory strategies.
Strong experience developing study protocols and other study documents, conducting literature reviews, and writing clinical sections of regulatory submissions.
Strong knowledge of 21 CFR Part 812, Good Clinical Practice, ISO 14155, and other applicable regulations and guidelines.
Basic understanding of statistics, statistical methods, and experimental design.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Must be comfortable in a hospital environment and able to work with nurses and surgeons.
Strong communication, presentation, and interpersonal skills, with attention to detail and organization.
Results-driven approach, strong problem-solving skills, and dedication and work ethic to meet aggressive timelines or manage multiple projects when necessary.
Ability to travel up to 30–40%.
May be required to provide current proof of vaccination against certain diseases, including COVID-19, depending on the role and customer requirements.

Nice To Haves

Previous experience supporting internal and external audits of clinical studies.
Existing or previous experience or familiarity with surgery or surgical technology.
Preference is 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.

Responsibilities

Contribute to and help develop the company’s clinical study strategy to meet business goals and objectives.
Collaborate with internal stakeholders and key opinion leaders to develop and review study concepts, protocols, and outlines, and drive identified initiatives.
Partner with Regulatory Affairs to support regulatory approval of new products and contribute clinical content to regulatory submissions.
Manage study resources and budgets to ensure studies are conducted on schedule, within budget, and with high quality and compliance.
Build lasting relationships with investigational sites and investigators for current and future studies.
Guide data management in developing case report forms and conducting data cleaning to support high-quality data collection.
Partner with biostatistics on study design, statistical analysis plans, analysis, interpretation, and synthesis for clinical study reports and scientific publications.
Ensure compliance with corporate procedures and regulatory requirements, including SOPs, GCP, and U.S. FDA regulations and guidelines; review departmental procedures and lead process improvement initiatives.
Set effective goals that are meaningful to the department and impactful to the organization.
Lead direct reports, provide ongoing guidance on internal and external communications, and support team members in achieving their goals and objectives.
Set and uphold high standards for individual and team competencies and performance.
Clarify complex issues and provide actionable direction, help the team prioritize and solve problems, and enable meaningful progress.
Develop talent and build a capable, effective team of clinical study managers and clinical research associates to manage studies efficiently.