Senior Manager, Clinical Affairs

Intuitive•Sunnyvale, CA

10h•$157,800 - $278,400•Onsite

About The Position

The Senior Manager of Clinical Affairs contributes to clinical strategies and oversees study execution for emerging technologies across various specialties. The portfolio may include U.S. and global first-human-use and pivotal clinical trials intended to support regulatory submissions. The role oversees clinical protocols and key study documents, clinical publications and evidence dissemination, and communications with clinical trial sites, contract research organizations, 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 professional development. The role works across Regulatory Affairs, R&D, the Program Management Office, Clinical Research Engineering, clinical research management, Global Access Value Economics, Global Public Affairs, Regulatory Compliance, Training, Legal, and commercial functions to optimize clinical study strategies and meet business objectives.

Requirements

Bachelor’s or Master’s degree in a scientific field, MD, or PhD, with 12 or more years of professional experience.
At least 5 years of independently managing clinical studies across phases, including pre-IDE, IDE submission, site selection and activation, study execution, data analysis and reporting, and closeout.
At least 3–5 years of supervisory experience is preferred.
Excellent clinical operations and project management skills, including experience collaborating with or leading cross-functional teams.
Demonstrated success managing 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 regulations and guidelines.
Basic understanding of statistics, statistical methods, and design of experiments.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Strong communication, presentation, interpersonal, organizational, and attention-to-detail skills.
Results-driven approach and strong problem-solving skills, with dedication and work ethic to meet aggressive timelines or manage multiple projects as needed.
Ability to travel up to 30–40%.

Nice To Haves

Previous experience supporting internal and external audits of clinical studies.
Comfort working in a hospital environment and experience working with nurses and surgeons.
Existing or previous familiarity with surgery or surgical technology.
At least 3–5 years of supervisory experience.

Responsibilities

Contribute to the company’s clinical study strategy and collaborate with internal stakeholders and key opinion leaders to develop and review study concepts, protocols, and outlines, then drive identified initiatives.
Partner with Regulatory Affairs to support regulatory approval of new products and contribute clinical content to regulatory submissions.
Manage clinical study resources and budgets to keep studies on schedule and within budget while maintaining quality and compliance.
Build and sustain relationships with investigational sites and investigators for current and future studies.
Guide case report form development and data cleaning in collaboration with data management to ensure high-quality data collection.
Work with biostatistics on study design, statistical analysis plans, analysis, interpretation, and synthesis; develop clinical study reports and support scientific publications.
Ensure compliance with corporate procedures and applicable regulatory requirements, including GCP and U.S. FDA regulations and guidelines; review departmental procedures and lead process improvements.
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.
Provide clear, actionable direction, help the team prioritize, and support resolution of complex problems.
Develop talent and build an effective team of clinical study managers and clinical research associates to manage studies efficiently.
Travel up to 30–40%.
Comply with any role- or customer-specific requirement to provide current proof of vaccination against certain diseases, if applicable.